C.F.A.S. HBA1C

Additional Manufacturer Narrative

THE LAST CALIBRATIONS PERFORMED ON 01-NOV-2022 AND 02-NOV-2022 WERE OK AND THERE WERE NO ALARMS. QUALITY CONTROLS WERE OUTSIDE OF RANGE INITIALLY ON 01-NOV-2022 AND RECOVERED WITHIN RANGE AFTERWARD. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, AN ABNORMAL ASPIRATION ALARM OCCURRED ON 02-NOV-2022. MULTIPLE SAMPLE SHORT ALARMS OCCURRED ON 05-NOV-2022 AND THIS CAN INDICATE POOR SAMPLE QUALITY. A CALIBRATION ALARM AND AN HBA1C SAMPLE CUP TYPE ERROR ALSO OCCURRED ON 05-NOV-2022. THE FIELD SERVICE ENGINEER DETERMINED THE CALIBRATOR MATERIAL WAS INCORRECTLY RECONSTITUTED. THE CUSTOMER USED 1 ML. OF WATER INSTEAD OF 2 ML. TO RECONSTITUTE THE CALIBRATOR MATERIAL. CONTROLS WERE OUTSIDE OF RANGE. A NEW CALIBRATION WAS PERFORMED WITH PROPERLY PREPARED MATERIAL. CONTROLS WERE WITHIN RANGE AND THE PATIENT SAMPLES WERE REPEATED AFTER THIS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 77 PATIENT SAMPLES TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT HBA1C RESULTS. THE CUSTOMER NOTED THAT THE HBA1C CALIBRATION PERFORMED ON (B)(6) 2022 HAD A LARGE JUMP IN SIGNAL VALUES. THE REAGENT PACK WAS THEN REMOVED ON (B)(6) 2022. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 10.7 % ON (B)(6) 2022 AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.9 %. THE REPEAT VALUE WAS DEEMED CORRECT. THE HBA1C REAGENT LOT NUMBER WAS 62959801, WITH AN EXPIRATION DATE OF 31-DEC-2023.