COBAS B 101 HBA1C TEST

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER IS WONDERING IF A DELAY IN TESTING (NOT WITHIN 60 SECONDS) WOULD HAVE CAUSED THE INITIAL HIGH RESULT OF 48 MMOL/MOL (6.5%). THE HBA1C DISC WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR HBA1C ON A COBAS B 101 INSTRUMENT. THE RESULT FROM THE INSTRUMENT USING A CAPILLARY FINGER PRICK WAS 48 MMOL/MOL (6.5%). THIS RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED AS IT WAS HIGH. THE PATIENT WAS TESTED THE SAME DAY AT THE LABORATORY USING AN EDTA WHOLE BLOOD SAMPLE AND THE RESULT WAS 30 MMOL/MOL (4.9%). THE SAMPLE AS REPEATED IN THE LABORATORY AND THE RESULT WAS 30 MMOL/MOL (4.9%). ON (B)(6) 2019 THE EDTA WHOLE BLOOD SAMPLE FROM THE LABORATORY WAS REPEATED ON THE B 101 INSTRUMENT WITH A RESULT OF 34 MMOL/MOL (5.4%). THE SERIAL NUMBER FOR THE COBAS B 101 INSTRUMENT SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER BATCH RECORD FOR COBAS B101 HBA1C DISC OF LOT 933042-01 HAS BEEN CONSULTED AND SHOWED NO ABNORMALITIES. THE MANUFACTURER FINAL PRODUCT INSPECTION REPORT FOR COBAS B101 HBA1C DISC OF LOT 933042-01 SHOWED NO ABNORMALITIES AND ALL FEATURES PASSED. THE COBAS B101 INSTRUMENT¿S LOG FILES THAT THE CUSTOMER UPLOADED HAVE BEEN ANALYZED BUT DID NOT CONTAIN CLEAR INDICATIONS THAT COULD IMPLICITLY CORROBORATE ANY RELATION TO THE ALLEGATION ON THE DATES OF THE MEASUREMENTS. THE MANUFACTURER HAS NOT SEEN DATA DEVIATION MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C DISCS OF LOT 933042-01 ON A RETENTION PHC COBAS B101 INSTRUMENT. THE MANUFACTURER DID NOT CONFIRM DISCREPANT RESULTS AND NO DEVIATING HBA1C RESULTS WERE FOUND. ALL OBTAINED RESULTS ARE ACCEPTABLE AND MEET SPECIFICATIONS. LOW RANGE DEVIATIONS WERE -0.3 - 0.1 % NGSP. AVERAGE DEVIATION WAS -0.12% NGSP. MIDDLE RANGE DEVIATIONS WERE -0.1 - 0.2% NGSP. AVERAGE DEVIATION WAS 0.05% NGSP. HIGH RANGE DEVIATIONS WERE -0.7 - 0.4% NGSP. AVERAGE DEVIATION WAS 0.51% NGSP. THE RETENTION MATERIAL MEASUREMENTS ON THE RETENTION COBAS B101 INSTRUMENT SHOWED NO HBA1C DEVIATION.