HK1118355B - Host apparatus and method providing calibration and reagent information to a measurement apparatus which makes use of a consumable reagent in a measuring process - Google Patents

Description

Host device and method for providing calibration and reagent information to a measurement device using a consumable reagent during a measurement process

Technical Field

The present invention relates to a measurement system and a method thereof, and particularly to a host device and a method for providing calibration and reagent information to a measurement device using a consumable reagent (consumable reagent) during a measurement process.

Background

Medical blood glucose meters are designed to measure the level of glucose in a patient's blood sample by using consumable reagents. Consumable reagents are typically of a chemical, biochemical or biological nature. Small amounts of appropriate consumable reagents are provided on disposable test strips. In use, a test strip is inserted into a blood glucose meter and a sample of patient blood provided to the test strip reacts with the consumable reagent. The glucometer, which includes a calibrated measurement system, measures a characteristic of a reaction between a reagent and a blood sample to determine an amount of glucose present in the blood sample.

It will be appreciated that in the case of a medical blood glucose meter, where treatment is determined based on the blood glucose measurement, the accuracy of the meter is critical. This requires very accurate calibration of the glucose meter. It is known to provide a disposable blood glucose test strip or a pack of such test strips with a machine readable memory on which calibration data is stored.

Current methods of how calibration data is provided to a medical glucose meter require a nurse to remove the machine-readable memory from the test strip package and insert it into a machine-readable memory slot of the medical glucose meter. The nurse then checks in each measurement that the lot identification code (lot identification code) read and displayed by the meter from the machine readable memory matches the lot number of the test strip actually used. To perform this task, the nurse scans the bar code either provided on the test strip pack using the glucometer or verifies that the displayed bar code matches the batch number printed on the pack. This approach causes several problems. For example, medical glucose meters must have a machine-readable memory slot that increases the size of the meter, increases the manufacturing cost of the meter, and allows liquid (cleaning agents) to enter the housing of the meter. Further, if the lot number of the test strip pack in use does not match the machine readable memory, such as in the case where the machine readable memory is misplaced; it is not easy to recover. This causes the operator to ignore this mismatch and continue the measurement, potentially leading to medical errors.

Disclosure of Invention

In order to prevent the above background, the present invention provides a host device and method for providing data, such as calibration data and reagent information, to a measurement device via connectivity over a network. The present invention allows the measurement device to download the necessary calibration data and reagent information from the host device by means of an appropriate electronic communication protocol. Such calibration data and reagent information may be either batch specific or generic. According to embodiments of the invention, the host device may be a computer/server of a point of care center (POCC), such as a Data Manager System (DMS), another measurement device using the same calibration data and reagent information, a dedicated connectivity device, a portable memory reader, and combinations thereof.

In one embodiment, a measurement system is provided, the measurement system comprising a network; a measurement device provided with a first set of lot identification codes, the measurement device configured to use a consumable reagent having an associated lot identification code in a measurement process, the measurement device configured to communicate the associated lot identification code of the consumable reagent over the network when the associated lot identification code does not match any of the first set of lot identification codes; and a host device provided with a second set of lot identification codes, each lot identification code having at least calibration data associated therewith, the host device being configured to receive the associated lot identification code of the consumable reagent transmitted from the measurement device over the network, to subsequently identify whether the received associated lot identification code matches any of the second set of lot identification codes, and to provide at least the calibration data associated with a lot identification code of the second set of lot identification codes to the measurement device over the network, wherein the second set of lot identification codes matches the associated lot identification code.

In another embodiment, a method is provided for obtaining test results using a measurement device and a consumable reagent, the method comprising providing a network; providing a first set of batch identification codes to the host device, each batch identification code having at least calibration data associated therewith; providing consumable reagents and an associated lot identification code; providing a second lot identification code to the measurement device; reading the associated lot identification code using the measurement device; transmitting the associated lot identification code of the consumable reagent to the host device over the network when the associated lot identification code does not match any of the second set of lot identification codes; identifying, using the host device, whether the received associated batch identifier matches any of the first set of batch identifiers; providing at least the calibration data associated with a batch identifier of the first set of batch identifiers matching the associated batch identifier to the measurement device over the network; and obtaining test results using the measurement device, the consumable reagent, and calibration data associated with the associated lot identification code received from the host device.

In yet another embodiment, there is provided a measurement system comprising: a removable machine-readable memory containing a lot identification code associated with a consumable reagent; a lot identification code removable machine-readable memory reader configured to read the lot identification code of the consumable reagent from the removable machine-readable memory; a measurement device configured to use the consumable reagent in a measurement process, wherein the measurement device is configured to communicate with the lot identification code reader to receive the lot identification code associated with the consumable reagent.

These and other features and advantages of the present invention will be more fully understood from the following description of various embodiments of the invention taken together with the accompanying drawings.

Drawings

The following detailed description of embodiments of the present invention can be best understood when read in conjunction with the following drawings, and in which:

FIG. 1 shows a measurement system embodying the present invention;

FIG. 2 illustrates a functional block diagram of an embodiment of circuitry for implementing the communications shown in FIG. 1;

FIG. 3 is a process flow diagram of one embodiment of providing at least calibration data to a medical measurement device; and is

Fig. 4 is a process flow diagram of another embodiment of providing at least calibration data to a medical measurement device.

Detailed Description

Fig. 1 shows a point of care center (POCC) measurement system, generally designated by the numeral 2, which is capable of providing calibration and other data to a measurement device, generally designated by the numeral 4, which is capable of using consumable reagents during a measurement procedure over a hospital's and other medical facility's network, generally designated by the numeral 6, as will be explained in detail below. The measuring device 4 is also able to send data via the network 6, as will be explained further below. It will be appreciated that the system 2 may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein.

In one embodiment, the measurement device 4 is a handheld diagnostic apparatus 10, such as a medical blood glucose meter. In other embodiments, the handheld diagnostic device 10 is any other medical diagnostic device that uses consumable reagents and requires periodic calibration data updates. In yet another embodiment, the measurement device 4 is a clinical chemistry analyzer 11 that uses consumable reagents and requires periodic calibration data updates. In the following discussion, it should be understood that the following system and method embodiments relate equally to the handheld diagnostic device 10 and the analyzer 11, and as such, only the handheld diagnostic device 10 is discussed in greater detail below.

In one particular illustrative embodiment, the measurement system 2 includes a handheld diagnostic device 10 having a microprocessor 5, a memory 8, a keypad 12, a display 14, and a battery unit (not shown) for powering the device. It should be understood that the keypad 12 and the display 14 may be one and the same, such as a touch screen. The apparatus 10 also includes a built-in measurement system 16, the system 16 being configured to measure an analyte, such as glucose, in a fluid (i.e., blood) sample from a patient under test using consumable reagents 18. The consumable reagent 18 is provided to a test carrier, such as a test strip 20 that may be elongated. The test carrier may also comprise a tape cartridge, a film, or any other suitable test carrier. The test strip 20 is inserted into a slot 22 in use, the slot 22 being provided in the apparatus 10 and which provides access to the measurement system 16.

In one embodiment, the measurement system 16, consumable reagent 18, and test strip 20 are of the type in which the microprocessor 5 determines that the test strip 20 is properly inserted into the apparatus 10 and that the excitation and sensing electrodes (not shown) of the test strip 20 exhibit proper electrode continuity. Before providing blood to the reagent 18, the microprocessor 5 causes the excitation power supply to apply an excitation voltage level to the excitation electrodes. Next, the patient's blood is provided to the reagent 18. In one embodiment, the test strip 20 uses a capillary to draw whole blood onto the test strip 20 and into the reagent 18, and in another embodiment, the test strip 20 may have a well (well) in which a drop of blood is provided to the reagent 18.

In one illustrative embodiment, the reagent 18 is potassium ferricyanide. Glucose in the blood sample provided to the reagent 18 causes a forward reaction of potassium ferricyanide toward potassium ferrocyanide. This forward reaction continues to complete during incubation. Subsequent application of an excitation voltage to the excitation electrode in the test strip 20 will cause a small current to be generated at the sensing electrode, which is caused by the reverse reaction of potassium ferrocyanide to potassium ferricyanide. The flow direction of electrons during the reverse reaction is sensed and measured by the device 10 at a number of points to enable a determination of the reaction along a Cottrell curve and further a determination of the level of the Cottrell curve, which is representative of the glucose concentration on the blood sample. The resulting glucose value (which is then corrected taking into account the ambient temperature) is then provided as the amount of glucose present in the blood sample. Such blood glucose measurement methods, consumable reagents 18, and test strips 20 are more particularly described in commonly assigned U.S. patent nos. 5,352,351 and 5,366,609, the disclosures of which are hereby incorporated by reference in their entirety. However, it should be understood that the system and method of the present invention is equally applicable to reflectometer-based measurement systems other than electrolysis-based measurement systems, or any other suitable assay system that uses consumable reagents that require manufacturer calibration data.

In addition to the consumable reagent 18, the test strip 20 and the container 21 from which the test strip 20 is provided, or both, are optionally provided with an identification code 24. The identification code 24 is a manufacturing lot number of the test piece 20. It should be understood that the lot identification code 24 may be extended to one or more test strip lots. The identification code 24 may be represented in such a way that it can be read visually or by at least one of an optical, magnetic, RF, electrical based identification code reader 26. In such an embodiment, the handheld diagnostic device 10 includes a suitable identification code reader 26 that is aligned with the slot 22, the identification code reader 26 reading the identification code 24 when the test strip 20 is inserted into the slot 22. The use of the identification code 24 is explained more fully below in the discussion of the various embodiments that follow.

The manufacturer or distributor of the test strip 20 maintains a central database 28, the central database 28 containing a lot data file 30, the lot data file 30 containing a set of identifiers 24₁，...，24_nEach identification code is associated with a calibration data set 32₁，...，32_nAnd (4) correlating. For reflectometer-based measurement systems, calibration data 32₁，...，32_nTypically including offset values and scaling factors (which may also provide non-linear calibration data) that may be used to correlate measured color changes with blood glucose levels. For an electrolysis-based measurement system, calibration data 32₁，...，32_nTypically including definitions of the test sequence (start and end times), measurement delay times, incubation times, the number of measurements made during a measurement, various thresholds against which voltage levels are compared, values of excitation voltage levels applied to the sample pieces during the test procedure, glucose value conversion factors, and various failsafe test threshold values. Calibration data 32 for each test strip lot₁，...，32_nThis is initially determined after manufacture of the batch, for example by comparing the results of tests performed using a typical measurement cell and by laboratory analysis. However, by retesting samples taken from each batch of residual test strip stock, the calibration data 32 is updated at regular intervals₁，...，32_n。

The handheld diagnostic device 10 relies on some suitable electronic communication protocol to download from the system 2 a batch data file 30 for accessing the required calibration data 32 from a host computer, generally indicated as 33₁，...，32_nThe calibration data is specific to one or more batches. The lot data files 30 may be accessed and downloaded by the device 10 from a host 33, the host 33 depending on the networking environment. For example, in one embodiment, the host 33 is a computer system of the POCC, such as a Data Manager System (DMS)34, that receives the lot data file 30 from the central database 28 via the Internet 36. The DMS34 then distributes the lot data file 30 to the device 10 via a wireless network 38 or a wired network 40. In one embodiment, the network connection of the device 10 is provided through an included network interface device 42, which network interface device 42 may be wired or wireless based. The wireless network 38 is a conventional wireless network and may provide an access point 39 through the POCC to facilitate wireless network connection to the DMS 34.

In another embodiment, the device 10 is connected to a networking docking station (docking station)44 having a network interface device 42. In this embodiment, the device 10 connects to the networked docking station 44 using the provided data and power connector 45 to interface with the wired network 40 or the wireless network 38 through the network interface device 42.

In another embodiment, using a disposable test strip pack, the lot data file 30 is provided and loaded in the removable machine readable memory 46 and the lot data file 30 is loaded into the DMS34 by the lot identification code reader 48 and then distributed to the device 10 via the wireless network 38 or the wired network 40. In yet another embodiment, the lot identification code reader 48 is portable and configured to wirelessly transmit the lot data file 30 contained in the removable machine-readable memory 46 to the device 10. In such embodiments, the lot identification code reader 48 may also transmit the lot data file 30 contained in the removable machine-readable memory 46 to the DMS34, the remote workstation 54, and the other devices 50, 58 via the wireless network 38 and/or the wired network 40.

In another embodiment, the host 33 may be a conventional device 50, such as a medical blood glucose meter having a machine-readable memory slot 52. In this embodiment, the machine-readable memory 46 containing the lot data file 30 is placed in a machine-readable memory slot 52 and transferred to a remote workstation 54 via an attached docking station 56. The lot data file 30 is then provided to the device 10 either by connecting the device 10 to a docking station 56 or by providing the lot data file 30 to the DMS34 via a remote workstation 54, the DMS34 redistributing the lot data file 30 to the device 10 via the wireless network 38 or the wired network 40. It should be appreciated that in another embodiment, the docking station 44 may be provided with a machine-readable memory slot 52 for the same purposes as described above.

In yet another embodiment, the host 33 may be another medical handheld diagnostic device 58 that is provided with the network interface device 42 and may host the device 10 and communicate over the wireless network 38 or through a peer-to-peer connection 60 (wired or wireless, e.g., infrared-based communication). In one embodiment, the handheld diagnostic device 58 is the same type of device as the device 10, such as both being a pair of blood glucose meters, and in other embodiments, the device 58 may be a different type of device than the device 10, but still using consumable reagents and requiring calibration data. Thus, in view of all of the above host embodiments, it should be understood that the communication of the batch data file 30 over the system 2 is dictated by the configuration of the system and/or network environment in which the device 10 is currently located, and its various embodiments are discussed in more detail in later sections with reference to FIGS. 3-6.

In FIG. 1, it should also be understood that measurement data may be communicated to the DMS34 and/or the remote workstation 54 at the time the measurement is performed, or it may be retained in the device 10 and transmitted to the DMS34 and/or the remote workstation 54 according to scheduling or other selection criteria. The measurement data may be routed from the device 10 to the DMS34 via the in-building wireless network 38 or via one of the docking stations 44 or 56. As shown, the docking station 56 is directly connected to the remote workstation 54 through the I/O port 62, and the remote workstation 54 may be programmed to provide updates to the DMS34 through the network connection 64.

The DMS34 is able to review the data for emergency situations and record the data for later use. Also, the DMS34 may monitor device status for proper operation and calibration. It should be understood that multiple servers or central stations, such as remote workstation 54, may be provided for communicating with the handheld diagnostic device. In addition, the DMS34 may transmit or simultaneously route data to the remote workstation 54 via the connection 64, or to an external computer 66 in the office of a hospital care provider via the Internet 36. It should be understood that the above data routing is provided as an example and is not limiting of the data routing used to provide the services described in accordance with the present invention.

Fig. 2 illustrates a functional block diagram of an embodiment of a circuit 68 for implementing the communications shown in fig. 1 and discussed above. The network connection 70 is connected to network processing circuitry. Many circuits may be used to provide network connectivity, such as including a network interface stack in one embodiment as part of the firmware running on the microcontroller 76. In yet another embodiment, a separate network processor 72 may be included for this functionality, such as SX-Stack from Scenixsemiconductor^TMChip, and iChip from Connect one electronics^TM. These integrated circuits and other available chips provide an interface layer for supporting the transmission control protocol/internet protocol (TCP/IP). TCP/IP is mentioned only as an example, however it should be understood that any other network transport protocol will be equally applicable to the present invention. In the latter embodiment, the network protocol processor 72 has an interface 74 with a microcontroller 76 that accesses conventional memory 78. To provide security and fault tolerance of the device 10, it is preferable for the microcontroller 76 or the internet protocol processor 72 to encrypt and provide a validation string or token in the data sent over the network, and thus decrypt the received information and validate the received string or token. The microcontroller 76 has an interface to the device circuitry 82The port 80, the device circuitry 82 in turn is configured with an interface 84 to the measurement system 16 shown in FIG. 1.

The measurement system 2 provides a mechanism to facilitate the performance and recording of measurements, such as glucose measurements, while it additionally provides for periodic instrument calibration, as well as the ability to ensure measurement and calibration compliance. Having information for one or more batches (i.e. by identification code 24'₁，...，24’_nIdentified lot) of calibration data 32₁，...，32_nCan be transferred from the instrument manufacturer to the field instrument or service organization so that the instruments and their calibrations can be recorded. The disclosed system 2 may be used to provide various mechanisms for ensuring calibration compliance. Various methods of ensuring proper calibration data are used in the testing of physical parameters, such as a patient's blood glucose level, which will now be described below with reference to fig. 1, 3 and 4.

Figure 3 illustrates one embodiment of a process 200 for ensuring calibration compliance within the device 10 by using the DMS34 as a host to download current calibration data to the hospital measurement device 4. In step 202, the lot identification code 24 is generated and assigned to each test strip lot production process. Calibration data 32 for each manufactured test strip lot is then generated in step 204. The batch data file 30 is generated in step 206 which associates each batch identification code 24 with the calibration data 32 generated in step 204. In one embodiment as shown in FIG. 1, the lot data file 30 contains a set of lot identification codes 24 for a current and a plurality of previous test strip lots₁，...，24_nAnd their associated calibration data 32₁，...，32_n. In one embodiment, the lot data file 30 provides at least the lot identification code 24 for the last three test strip lot production runs₁，...，24_nAnd their associated calibration data 32₁，...，32_n. In other embodiments, the set may be any suitable number of batch identification codes and their associated calibration data.

In step 208, in one embodiment, the lot data file 30 is electronically distributed from the central database 28 to the POCC DMS34 via the internet 36. It should be understood that the lot data files 30 may be distributed to the customer in different ways, such as mailing a CD, sending an email, or providing a URL for the customer to download data from the central database 28. One or more of these distribution methods may be selected and all of these methods may be protected to ensure confidentiality, integrity, and authenticity of the content in the published lot data file 30.

In one embodiment, the lot data file 30 is encrypted using a standard encryption application before being sent to the POCC DMS 34. If desired, the operator of the POCC DMS34 decrypts the lot data file 30 using a standard decryption application compatible with the encryption application, and checks the lot data file 30 to verify that its lot identification code 24 matches the lot identification code 24 of the test strip for the POCC in step 210. Once verified, the operator issues the lot data file 30 to the DMS34 for general download/update by the measurement device 4 within the system 2 in step 212. The measurement device 4, such as the device 10, the analyzer 11, and even other hosts 33, will download the lot data file 30 into its memory 8 in step 214 the next time it connects or communicates with the DMS 34.

In parallel with the above-described batch data file generation steps 202, 204, and 206, test strip batch production and test strip batch packaging and labeling occur in steps 216 and 218, respectively. The test strip serial number is loaded by the manufacturer in step 220, and the test strip serial number is received and verified by the POCC in step 222. In one embodiment, it should be understood that the batch data file 30 may be sent with a serial number on a machine-readable memory, such as the machine-readable memory 46 shown in FIG. 1. Following the batch identification code verification in step 222 (or step 210), the POCC distributes the single-use test strips throughout the desired patient room in step 226, the test strips typically being packaged in a container 224, the container 224 holding a quantity of test strips. It should be appreciated that each container 224 has a label 228 that identifies at least the expiration date, and the assigned lot identification code 24. The process 200 then continues hereinafter using the device 10, such as during a blood glucose test.

In the illustrated embodiment, in which the device 10 is a medical blood glucose meter, to begin a blood glucose test, the nurse activates a measurement sequence using a menu displayed on the display 14 of the handheld diagnostic device. In the embodiment shown in figure 3, from the menu displayed, the nurse will select the available lot identification code 24 'read from the memory 8 of the device 10 in step 230'₁，...，24’_nOne of which becomes the "current" batch identifier. After selecting the current lot identification code, the device 10 will display a portion (e.g., the last three digits) of the current lot identification code prior to each blood glucose test in step 232, which begins by inserting a single use test strip into the slot 22. Prior to insertion, the nurse places a small amount of the patient's blood over the reagent 18 provided on the test strip 20. After a while, the test strip 20 is completely inserted into the groove 22. Once inserted, the nurse will then be prompted by device 10 at each measurement to verify in step 234 that the displayed portion of the current lot identification code matches the same portion of the lot identification code provided on label 228 of container 226 and that disposable test strip 20 is removed from container 226. Upon this verification, and the nurse confirming the selection to continue the test from the displayed prompt provided on the device 10 in step 236, the measurement system 16 will determine the change in the reagent 18 in step 238.

The handheld diagnostic device 10 then proceeds to calculate blood glucose test results using the measured change in the reagent 18, the calibration data 32, and the calculation algorithm, where the calibration data 32 is read from the lot data file 30 stored in the memory 8 and corresponds to the selected current lot identification code 24, and the calculation algorithm is pre-stored and also read from the memory 8. This calculation is performed by the microprocessor 5 of the handheld diagnostic device 10. The result is then displayed on the display 14 in step 240 and also stored on the memory 8 of the device.

Another embodiment is shown in fig. 4, where like steps discussed with respect to fig. 3 are identified with like reference numerals and, therefore, for the sake of brevity, only the differences between the embodiments are discussed below. In the case where the lot identification code 24 of the test strip is provided on the test strip 20, the device 10 reads the identification code 24 using the included identification code reader 26 as soon as the test strip 20 is inserted into the device 10 through the slot 22 in step 242. In an alternative embodiment, in step 242, the nurse scans the label 228 using the identification code reader 26 of the device 10 to read the lot identification code 24 of the test strip.

Next, in step 244, the device 10 checks whether the read batch identification code 24 matches the batch identification code 24 'provided in the batch data file 30 stored in the memory 8'₁，...，24’_n. If the read batch identification code 24 matches the batch identification code 24 'provided in the stored batch data file 30 of the device 10'₁，...，24’_nOne, then the device will automatically select the read batch identification code 24 as the current batch identification code in step 246. If the batch identification code 24 read in step 244 does not match the batch identification code 24 'contained in the batch data file 30 stored in the memory 8 of the device 10'₁，...，24’_nOne, then in step 248 the device 10 automatically initiates a data call to the host 33 available on the system 2 for updating.

As described above, the host 33 may be the docking station 44, another medical handheld diagnostic device 50 or 58, the remote workstation 54, and/or the DMS34, depending on the system environment. Thus, in one embodiment, the host 33 is another medical handheld diagnostic device from which the device 10 receives at least the required calibration data, which data is specific to one or more batches. In one embodiment, the connections between devices 10, 50, and 58 are direct connections, and in another embodiment, the connections between devices 10, 50, and 58 are indirect connections having at least one intermediate device through which data passes. In another embodiment, the host 33 is a dedicated connection device 44, 48 or 50 having a machine-readable memory slot 52 that can be loaded with machine-readable memory 46 from which the device 10 receives at least the required calibration data, either directly or indirectly, such as through a remote workstation 54, wired network 40 or wireless network 38. In another embodiment, the host 33 is a computer system of the POCC, such as DMS34, and the device receives at least the calibration data through the connection 38, 40, or 56 to the DMS 34.

In step 250, the device 10 checks to see if the host 33 is found. If the device 10 is not connected to the host 33, the device 10 prompts the nurse to initiate a data call to the host 33 of the system 2 using a message displayed on the display 14 of the handheld diagnostic device in step 252. After the prompt is received by the nurse in step 252, the host 33 is discovered and connected in step 250, and the handheld diagnostic device 10 transmits the read batch identification code 24 to the available host in step 254. In step 256, the available host checks to see if the received batch identifier 24 matches the batch identifier 24 contained in the batch data file 30 in which it is stored₁，...，24_nOne of them responds. If there is a match at step 256, the host sends the updated lot data file 30 or at least the required calibration data 32 back to the handheld diagnostic device 10 through the system 2 at step 258. The process then continues in step 246, as described above with respect to fig. 3.

If there is no match in step 256, then the host 33 checks to see if it is a DMS34 in step 260. Because only verified and approved lots have been issued to the patient's room, if the forwarded lot identification code does not match the lot identification code 24 in the lot data file 30 provided on the DMS34₁，...，24_nOne, a message is sent to the device 10 indicating that the test strip lot is not approved for use, and the device 10 requests the updated lot data file from the DMS34 in step 262. Similar messages may be sent to designated individuals so that corrective action may be taken to determine why test strips are not approved for use, such as in the case of expired lots or unpublished/unverified lots, which may have been incorrectly assigned.

If the host 33 is not the DMS34 in step 260, the host checks to see if it is connected to the DMS34 in step 264. If the host 33 is not connected to the DMS34, then the message is displayed on the device and/or host 33 to connect directly to the DMS34 for updating in step 266. After connecting to the DMS34, then the device or host forwards the received lot identification code to the DMS34 for review in step 268, as the new or updated lot data file 30 received from the central database 28 is available for download from the DMS 34. The process then continues in step 256 as described above except that the host is the DMS34, and then continues with the process steps as explained above with reference to figure 3.

It will be appreciated that in the case of expired lots, the device 10 and host 33 are programmed in one embodiment to delete a particular lot identification code from the available lot data files 30 on the network, which data files 30 exceed the expiration date provided on the lot data files. In this manner, the "unapproved use" message described above will be displayed on the device 10 in step 262 after the product expiration period. In another embodiment, the device 10 may check the expiration date provided on the lot data file 30 corresponding to the read lot identification code 24, and if the current date provided by the device's internal clock exceeds the expiration date, the device will not perform the blood glucose test and will provide a message to the nurse that the test strip lot is expired.

It should be appreciated that the results provided in step 240 may be obtained by transmitting the measured change along with the batch identification code 24 from the handheld diagnostic device 10 to one of the hosts 34, 44, 48, 50, 54, 58. The available host computer 33 may then process the measured values using the calibration data from the lot data file 30 to generate test results. Then, it is not necessary to send calibration data to the handheld diagnostic device 10 and only the test results need to be transmitted. The results received by the handheld diagnostic device 10 may then be displayed directly on the display of the handheld diagnostic device.

It should also be appreciated that the above-described embodiments may be combined in any of a variety of combinations in order to maximize the benefit of the customer. Further, it should be appreciated that transmitting calibration data to the medical handheld diagnostic device 10 by means of electronic data communication rather than by providing the machine readable memory 46 results in increased reliability by ensuring that the most recent calibration data is used for the measurement system 2 before performing a blood glucose test using the device 10.

In addition to providing the most up-to-date calibration data of the test system 2, the system provides a number of other important benefits in blood testing. For example, it should be appreciated that the present invention allows construction of a medical handheld diagnostic device without a machine readable memory slot, which reduces device cost, eliminates a major cause of device breakage by making it more robust against cleaning and static discharge, and eliminates one of the most frequent usage errors in the field, i.e., erroneous calibration data. This usage error may lead to unnecessary repeated measurements or medical diagnostic errors. Finally, it should be understood that the present invention is fully compatible with current and future calibration and code assignment methods, and does not limit chemical development and the manufacture of blood glucose test strips. The invention thus allows the manufacturer to change the raw materials and environmental conditions, or even adapt the calibration to the specific needs of a specific country, without changing the device design.

With respect to the above disclosure, it should be appreciated that the present invention (which relates to providing manufacturer calibration data over a wired or wireless network) has useful application in handheld and desktop point-of-care or proximity patient testing systems, as well as in fully automated, computerized clinical chemistry analyzers 11 (FIG. 1) for central laboratories and using multiple consumable reagents 18. Such chemical analyzers 11 are for example the Roche/Hitachi MODULAR ANALYTICS, Roche COBAS Integra and/or Roche COBAS 6000 systems, which are fully automated, software-controlled systems for clinical chemistry and immunoassay analysis, designed for quantitative and qualitative crystallite determination using a large number of tests for analysis. Because the provision of calibration data and other information for the handheld diagnostic device 10 may be accomplished in the same manner as described above, further discussion is not provided for convenience.

The above description and drawings are only to be considered illustrative of exemplary embodiments, which achieve the features and benefits of the present invention. Modifications and substitutions to specific process steps, systems, and architectures can be made without departing from the spirit and scope of the present invention. Accordingly, the invention is not to be seen as limited by the foregoing description and drawings, but is only limited by the scope of the appended claims.

Claims (57)

1. A measurement system (2) comprising:

a network (6);

a measuring device (4) provided with a first set of inclusion identification codes (24'₁，...，24’_n) Each of these identification codes is associated with corresponding calibration data (32) (30') of a batch data file₁’，...，32_n') related, the measuring device (4) being configured to use a consumable reagent (18) during a measurement, the consumable reagent (18) having a contained identification code (24)₁，...，24_n) Related lot data file(30) Each of these identification codes is associated with corresponding calibration data (32)₁，...，32_n) -correlation, -the measuring device (4) being configured to determine if the correlated batch identification code (24) does not match the first set of batch identification codes (24'₁，...，24’_n) Transmit the associated lot data file (30) of the consumable reagent (18) over the network (6) at any one of the time; and

a host device (33) provided with a second batch identification code (24)₁，...，24_n) Each identification code having at least calibration data (32) associated therewith₁，...，32_n) The host device (33) being configured to receive an identification code (24) containing the consumable reagent (18) transmitted from the measurement device (4) over the network (6)₁，...，24_n) Of the associated lot data file (30), each of these identification codes being associated with corresponding calibration data (32)₁，...，32_n) Correlating to subsequently identify whether the received correlated batch identification code (24) matches the second batch identification code (24)₁，...，24_n) And to distribute the lot data file (30) of the consumable reagents over the network (6).

2. The measurement system of claim 1, wherein the network is an indoor wireless network (38).

3. The measurement system of claim 1, wherein the network is a wired network (40).

4. The measurement system of claim 1, wherein the network is a peer-to-peer connection (60).

5. The measurement system of claim 1, wherein the network is selected from the group consisting of an indoor wireless network (38), a wired network (40), a peer-to-peer connection (60), and combinations thereof.

6. The measurement system of claim 1, wherein the measurement device is a handheld diagnostic device (10).

7. The measurement system of claim 1, wherein the measurement device is a clinical chemistry analyzer (11).

8. The measurement system of claim 1, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot data file (30) of the consumable reagent (18).

9. The measurement system of claim 1, wherein the associated lot identification code (24) is provided in a machine readable memory (46), the machine readable memory (46) being removable from the consumable reagent or test strip or a container in which the test strip is provided, and the measurement device is in communication with a reader (48) for the machine readable memory which reads the machine readable memory (46) to provide the associated lot data file (30) to the measurement device.

10. The measurement system of claim 1, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot data file (30) of the consumable reagent (18), wherein the associated lot data file (30) is a radio frequency identification tag and the lot identification code reader (26) is a radio frequency identification tag reader.

11. The measurement system of claim 1, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot data file (30) of the consumable reagent (18), wherein the associated lot data file (30) is a magnetic identification tag and the lot identification code reader (26) is a magnetic identification tag reader.

12. The measurement system of claim 1, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot data file (30) of the consumable reagent (18), wherein the consumable reagent is provided on a single-use test strip (20) and the associated lot data file (30) is provided on a container (21), the container (21) providing the single-use test strip (20).

13. The measurement system of claim 1, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot data file (30) of the consumable reagent (18), wherein the consumable reagent is provided on a single-use test strip (20) and the associated lot data file (30) is provided on the single-use test strip (20).

14. The measurement system of claim 1, wherein the host device is a data management system (34).

15. The measurement system of claim 1, wherein the host device is another measurement device (50, 58).

16. The measurement system of claim 1, wherein the host device is a computer workstation (54).

17. The measurement system of claim 1, wherein the host device is a docking station (44).

18. The measurement system of claim 1, wherein the host device is a reader (48) for a machine-readable memory, and the machine-readable memory (46) is removable from the consumable reagent, the test strip, or the container in which the test strip is provided.

19. The measurement system of claim 1, wherein said second set of lot identification codes (24)₁，...，24_n) And said calibration data (32)₁，...，32_n) Is provided in a memory of the host device, wherein the memory is a machine readable memory (46) removable from the consumable reagent, test strip or container in which the test strip is provided.

20. The measurement system of claim 1, wherein said second set of lot identification codes (24)₁，...，24_n) And said calibration data (32)₁，...，32_n) Is provided in a memory of the host device, wherein the memory is a machine readable memory (46) removable from the consumable reagent, test strip or container in which the test strip is provided, and the host device is a docking station (44).

21. The measurement system of claim 1, wherein said host device accesses a memory (8, 46) containing said second set of lot identification codes (24)₁，...，24_n) And said calibration data (32)₁，...，32_n)。

22. The measurement system of claim 1, further comprising a database (28) in communication with said host device, said database containing said second lot identification code (24)₁，...，24_n) And said calibration data (32)₁，...，32_n)。

23. The measurement system of claim 1, further comprising a database (28) in communication with said host device over a public network (36), said database containing said second lot identification code (24)₁，...，24_n) And said calibration data (32)₁，...，32_n)。

24. The measurement system of claim 1, wherein the measurement device has a display (14) and is configured for use with the measurement deviceThe calibration data (32) related to the batch identification code (24)₁，...，32_n) A test result is calculated and configured to display the test result on the display.

25. The measurement system of claim 1, wherein the calibration data (32)₁，...，32_n) Is specific to one or more batches of consumable reagents (18).

26. The measurement system of claim 1, wherein said host device is further configured to use said second lot identification code (24)₁，...，24_n) The batch identification code (24) of (a) is related to the calibration data (32)₁，...，32_n) A test result is calculated and configured to provide the test result to the measurement device.

27. A method of obtaining test results using a measurement device (4) and a consumable reagent (18), the method comprising:

providing a network (6);

providing the first batch identification code (24) to the host device (33)₁，...，24_n) Each identification code having associated therewith at least calibration data (32)₁，...，32_n)；

Providing a consumable reagent (18) and an associated lot data file (30) containing identification codes (24), each of which is associated with corresponding calibration data (32);

providing a second set of batch identification codes (24 ') to the measurement device (4)'₁，...，24’_n)；

Reading a contained identification code (24) using the measuring device (4)₁，...，24_n) The associated lot data file (30) of the consumable reagent (18), each of these identification codes being associated with corresponding calibration data (32)₁，...，32_n) Correlation;

when the associated batch identification code (24) does not match the second set of batch identification codes (24'₁，...，24’_n) Any one of-transmitting said associated lot data file (30) of said consumable reagent (18) to said host device (33) via said network (6);

identifying, using the host device (33), whether the received associated batch identification code (24) matches the first set of batch identification codes (24)₁，...，24_n) Any one of the above;

-distributing the lot data file (30) of the consumable reagent (18) over the network (6); and is

Obtaining a test result using the measurement device (4), the consumable reagent (18), and calibration data (32) associated with the associated lot identification code (24) received from the host device (33).

28. The method of claim 27, wherein the network is an indoor wireless network (38).

29. The method of claim 27, wherein the network is a wired network (40).

30. The method of claim 27, wherein said network is a peer-to-peer connection (60).

31. The method of claim 27, wherein said network is selected from the group consisting of an indoor wireless network (38), a wired network (40), a peer-to-peer connection (60), and combinations thereof.

32. The method of claim 27, wherein the measurement device is a blood glucose meter (10).

33. The method of claim 27, wherein the measurement device includes a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith.

34. The method of claim 27, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith, wherein at least the associated lot identification code (24) having at least the calibration data (32) associated therewith is a bar code and the lot identification code reader (26) is a bar code reader.

35. The method of claim 27, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith, wherein at least the associated lot identification code (24) having at least the calibration data (32) associated therewith is a radio frequency identification tag, and the lot identification code reader (26) is a radio frequency identification tag reader.

36. The method of claim 27, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith, wherein at least the associated lot identification code (24) having the calibration data (32) associated therewith is a magnetic identification tag, and the lot identification code reader (26) is a magnetic identification tag reader.

37. The method of claim 27, wherein the measurement device comprises a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith, the consumable reagent being provided on a single-use test strip (20) and the associated lot identification code (24) having at least calibration data (32) associated therewith being provided on a container (21), the container (21) providing the single-use test strip (20).

38. The method of claim 27, wherein the measurement device includes a lot identification code reader (26) configured to read the associated lot identification code (24) of the consumable reagent (18), the associated lot identification code (24) having at least calibration data (32) associated therewith, wherein the consumable reagent is provided on a single use test strip (20) and the associated lot identification code (24) having at least calibration data (32) associated therewith is provided on the single use test strip (20).

39. The method of claim 27, wherein the host device is a data management system (34).

40. The method of claim 27, wherein the host device is another measurement device (50, 58).

41. The method of claim 27, wherein the host device is a computer workstation (54).

42. The method of claim 27, wherein the host device is a docking station (44).

43. The method of claim 27, wherein the host device is a reader (48) for a machine-readable memory, and the machine-readable memory (46) is removable from the consumable reagent, test strip, or container in which the test strip is provided.

44. The method of claim 27, wherein said second set of batch identification codes (24'₁，...，24’_n) And said calibration data (32)₁，...，32_n) Is provided in a memory of the host device, wherein the memory is a removable machine-readable memory (46) removable from the consumable reagent, the test strip or a container in which the test strip is provided.

45. The method of claim 27, wherein said second set of batch identification codes (24'₁，...，24’_n) And said calibration data (32)₁，...，32_n) Is provided in a memory of the host device, wherein the memory is a removable machine-readable memory (46) removable from the consumable reagent, test strip or container in which the test strip is provided, and the host device is a docking station (44).

46. The method of claim 27, wherein said host device accesses a memory (8, 46) containing said second set of batch identification codes (24'₁，...，24’_n) And said calibration data (32)₁，...，32_n)。

47. The method of claim 27, further comprising a database (28) in communication with said host device, said database (28) containing said second set of batch identification codes (24'₁，...，24’_n) And said calibration data (32)₁，...，32_n)。

48. The method of claim 27, further comprising a database (28) in communication with the host device over a public network (36), the database including the second set of batch identification codes (24'₁，...，24’_n) And said calibration data (32)₁，...，32_n)。

49. The method of claim 27 wherein the measurement device has a display (14) and is configured to calculate a test result using the calibration data (32) associated with the associated lot identification code (24) and is configured to display the test result on the display.

50. The method of claim 27, wherein if there is no match, the method further comprises displaying a message on the measurement device to indicate that the reagent (18) is not approved for use.

51. The method of claim 27, wherein if there is no match, the method further comprises displaying a message on the measurement device to indicate that the reagent (18) is not approved for use, and sending a similar message to the designated individual so that corrective action can be taken.

52. The method of claim 27, wherein the associated lot identification code (24) has an associated expiration date, wherein the method further comprises displaying a message on the measurement device to indicate that the reagent is not approved for use after the expiration date.

53. The method of claim 27, wherein the measuring device is a clinical chemistry analyzer (11).

54. The method of claim 27, wherein said calibration data (32)₁，...，32_n) Is specific to one or more batches of said consumable reagent (18).

55. A measurement system (2) comprising:

a machine readable memory (46) removable from the consumable reagent, test strip or container in which the test strip is provided, containing a lot identification code (24) associated with the consumable reagent (18);

a portable reader (48) for a machine-readable memory configured to read the lot identification code (24) of the consumable reagent (18) from the removable machine-readable memory (46), wherein the machine-readable memory is removable from the consumable reagent, a test strip, or a container in which the test strip is provided; and

a measurement device (4) configured to use the consumable reagent (18) in a measurement process, wherein the measurement device (4) is configured to communicate with the reader (48) to receive the lot identification code (24) associated with the consumable reagent (18).

56. The measurement system of claim 55, wherein the measurement device and the batch reader are configured to communicate (38) wirelessly.

57. The measurement system of claim 55, wherein the reader is portable and the measurement device and the reader are configured to communicate wirelessly (38).