Subject: Cholesterol Gen.2 04718917 190 All lots in Creatinine plus ver.2 04657489 190 market CRP latex 04657497 190 Glucose HK 04657527 190 Total Protein Gen.2 monochrom. 04657586 190 Triglycerides 04657594 190 Urea/BUN 04657616 190
Issue: Correction of setting of last calculation point [CalcLastUsed]
on cobas c 111
Date: 25 April, 2007
Instrument/System Component Remark
COBAS INTEGRA® Reagent/cal/control Customer info suggested Roche/Hitachi ISE Company info cobas c 501 Software Product education cobas c 111 Documentation Control recovery affected Sample recovery affected Recovery not affected Attachments: BTS sheets included
Executive Summary
The last measuring point - CalcLastUsed - on cobas c 111 has been erroneously set to the default setting of cycle no. 40 which results in an unnecessary delay of the printout of test results. The correct setting has now been implemented in the application and the corresponding Barcode Transfer Sheets (BTS).
CM Clarify: n/a CAPA No. n/a
V:\_organisation\Lg_TR\Product Bulletins CC HIA\2007\pb07-045.doc
cobas and cobas c are trademarks of Roche 1/3 Dear Colleagues,
Background:
The delta absorbance between first and last measuring point of an application is used as basis for the calculation of test results on cobas c 111. The results can be printed out immediately after the last measuring point and this is implemented in the instrument software as CalcLastUsed. The cycle programmed for the printout thus depends on the application. However, in the following assays the CalcLastUsed was erroneously set to the default of cycle 40.
¾ Cholesterol Gen.2, Creatinine plus ver.2, CRP (latex), Glucose HK,
Total Protein Gen.2 monochromatic, Triglycerides, Urea / BUN
Root Cause:
Handling error occurred during application setting
Consequence:
The erroneous setting of CalcLastUsed to cycle 40 forces the printout to be
unnecessarily delayed to 12 minutes. This situation is unacceptable for customers.
Adjustment of CalcLastUsed setting:
Method ACN Ver 02 Last measuring Reporting
point (cycle) time (min) CHOL2 798/433 37 11.1 CREP2 652 34 10.2 CRPLX 019 25 7.5 GLUC2 767 37 11.1 TP2M 227* 33 9.9 TRIGL 781 21 6.3 UREAL 418 13 3.9 *ACN 227 Ver. 03 has been released with a further change: QC Flag is set from OFF to ON
The corrected barcode transfer sheets are attached. Customers affected must re-load the modified Barcode Transfer Sheets (BTS) on their cobas c 111 analyzer.
Schedule of Corrective and Preventative Actions (CAPA):
Actions Anticipated Completion 1. Modified BTS sheets for cobas c 111 to be provided by April 2007 labelling department 2. Affiliates to be informed by Product Bulletin April 2007 3. Customers to be informed by affiliates May 2007
3/3 ® CHOL2 cobas c 111 04718917 190 BTS c 111-04718917 01 02
Cholesterol Gen.2
Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής ACN 798/433 Ver 01 02 reporting time (min.) 12.0 11.1
Application Barcode Application Barcode
ACN 798 - CHO2I (ID-MS) ACN 433 - CHO2A (Abell-Kendall) Ver 02 Ver 02
| 1111 ® CREP2 cobas c 111 04657489 190 BTS c 111-04657489 01 02
Creatinine plus ver.2
Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής ACN 652 Ver 01 02 reporting time (min.) 12.0 10.2
Application Barcode Application Barcode
ACN 652 - CRE2 - Serum ACN 653 - CRE2U - Urine Ver 02 Ver 01
| ® CRPLX cobas c 111 04657497 190 BTS c 111-04657497 01 02
C-reactive protein (latex)
Application Barcode Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da ACN 019 modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Ver 02 Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής
| 1111 ® GLUC2 cobas c 111 04657527 190 BTS c 111-04657527 01 02
Glucose HK
Application Barcode Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da ACN 767 - GLU2 modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Ver 02 Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής
| 1111 ® TP2M cobas c 111 04657586 190 BTS c 111-04657586 01 02
Total Protein Gen.2 monochromatic
Application Barcode Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da ACN 227 modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Ver 02 Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής
| ® TRIGL cobas c 111 04657594 190 BTS c 111-04657594 01 02
Triglycerides
Application Barcode Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da ACN 781 modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Ver 02 Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής
| 1111 ® UREAL cobas c 111 04657616 190 BTS c 111-04657616 01 02
Urea / BUN
Application Barcode Reason for change / Änderungsgrund / Motif du changement /
Razón de la modificación / Causa del cambiamento / Causa da ACN 418 - UREL modificação / Orsak till ändring / Årsag til ændring / Příčina změny/ Ver 02 Dôvod zmeny / Przyczyna zmiany / Változás oka / Αιτία αλλαγής
