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

Additional Manufacturer Narrative

THE HBA1C REAGENT LOT NUMBER WAS 80515001 WITH AN EXPIRATION DATE OF 31-MAR-2026. THE QC WAS RUNNING HIGH BUT STILL WITHIN RANGE. THE FIELD SERVICE ENGINEER FOUND THAT THE RINSE VOLUMES AT THE PROBE, RINSE BATHS, AND RINSE MECHANISMS WERE LOW. HE PERFORMED A HEALTH CHECK, CHECKED THE MECHANICAL ADJUSTMENTS OF THE PROBES, AND ADJUSTED RINSE VOLUMES AND PUMP PRESSURE. HE THEN PERFORMED CALIBRATION, QC, AND PRECISION STUDIES, AND THEY WERE WITHIN SPECIFICATIONS. THE ANALYZER WAS THEN PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C (HBA1C) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 5.9 %. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED AT THE SAME FACILITY AND AT A SISTER LABORATORY. 1ST REPEAT RESULT: 6.5 % (REPEATED ON ANOTHER C501). THE 2ND REPEAT RESULT OBTAINED FROM THE SISTER LABORATORY WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

SECTIONS D1, D2A, D2B, D4, G1 AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER REPLACED THE GEAR PUMP. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.