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

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR 61 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. ONLY 2 PATIENT EXAMPLES WERE PROVIDED. PATIENT 1: THE INITIAL RESULT WAS 9.05%. THE REPEATED RESULT WAS 6.20%. PATIENT 2: THE INITIAL RESULT WAS 14.6%, AND THE REPEATED RESULT WAS 9.6% THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER'S QC FAILED. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6) . THE FIELD SERVICE REPRESENTATIVE NOTED THAT THE SAMPLE PROBE APPEARED TO BE CLEAN. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE ISSUE WAS A USER ERROR WHEN PERFORMING THE ASSAY CALIBRATION. THE CUSTOMER CALIBRATED ONE REAGENT PACK WITH ONLY 1 OF THE 2 CALIBRATIONS NEEDED FOR THE ASSAY. THE OTHER CALIBRATION WAS PERFORMED ON A DIFFERENT REAGENT PACK AN HOUR LATER. THE CUSTOMER PERFORMED A NEW CALIBRATION CORRECTLY, AND THE ISSUE WAS RESOLVED.