TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION

Additional Manufacturer Narrative

QC RECOVERY WAS OUT OF RANGE ON THE DATE OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT A SPECIFIC ROOT CAUSE WAS NOT FOUND AND PERFORMED A DECONTAMINATION, REPLACED ALL PIPETTOR SEALS, VACUUM VALVES, RINSE MECHANISM TUBING, DETERGENT VACUUM TUBING, ALL CELLS, VACUUM DIAPHRAGMS, FLAPPER VALVES, AND THE GEAR PUMP HEAD. THE FSE VERIFIED ALL MECHANISMS WERE ADJUSTED AND WORKING PROPERLY, ALL WATER AND VACUUM PRESSURES, AND COMPLETED CALIBRATION AND QC FOR HBA1C; ALL RESULTS WERE PASSING. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE; THE INSTRUMENT WAS VERIFIED, AND THE SERVICE ACTIONS APPEAR TO HAVE RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT WAS 14.6% ON (B)(6) 2024, AND THE REPEAT RESULT WAS 6.8%. PATIENT 2'S INITIAL RESULT WAS 9.3% ON (B)(6) 2025, AND THE REPEAT RESULT WAS 5.6%. PATIENT 3'S INITIAL RESULT WAS 7.6% ON (B)(6) 2025, AND THE REPEAT RESULT WAS 5.4%. PATIENT 3'S QUESTIONABLE RESULT WAS REPEATED BECAUSE THE DOCTOR QUESTIONED THE RESULT. PATIENT 1 & 2 WERE REPEATED DUE TO A DELTA CHECK.