TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

THE HBA1C REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS C503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE DATA WAS REQUESTED FOR INVESTIGATION BUT IT WAS NOT PROVIDED DESPITE SEVERAL REMINDERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT HBA1C RESULTS FOR AROUND 50 PATIENTS' SAMPLES TESTED ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT ANALYZER. DISCREPANT HBA1C RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED. INITIAL RESULT: 7%. THE SAME SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT AND THE REPEAT RESULT WAS 10%. IT IS UNCLEAR IF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THIS INFORMATION WAS REQUESTED BUT IT WAS NOT PROVIDED.