TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

THE HBA1C REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS PURE C303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE WITHIN RANGES PRIOR TO THE EVENT. THE ALARM TRACE SHOWED ABNORMAL ASPIRATION ALARMS FOR THE SAMPLE PROBE. THE CELLS ARE REPLACED MONTHLY. THE SAMPLE PROBE WAS CHECKED AND NO ISSUES WERE FOUND. ALL RINSE LEVELS FOR THE CELLS AND THE PROBES WERE ADJUSTED CORRECTLY. THE REAGENT PROBES WERE ADJUSTED CORRECTLY. THE CELLS GET COMPLETELY DRY AFTER CELL WASH. THERE WAS NO VISIBLE RESIDUAL WATER IN THE CELLS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH HBA1C ON A COBAS PURE C303 ANALYTICAL UNIT. SAMPLE 1 (PATIENT 1) WAS TESTED ON 26-SEP-2024: INITIAL RESULT: 10.5 % (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 6.11 %. THIS SAMPLE WAS A WHOLE BLOOD SAMPLE. SAMPLE 2, SAMPLE 3, SAMPLE 4, AND SAMPLE 5 WERE TESTED ON 14-OCT-2024: SAMPLE 2 (PATIENT 2): INITIAL RESULT: 8.00 %. REPEAT RESULT: 5.22 %. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 6.88 %. REPEAT RESULT: 4.70 %. SAMPLE 4 (PATIENT 4): INITIAL RESULT: 7.49 %. REPEAT RESULT: 5.14 %. SAMPLE 5 (PATIENT 5): INITIAL RESULT: 7.87 %. REPEAT RESULT: 4.96 %.

Additional Manufacturer Narrative

THE REQUESTED DATA FOR INVESTIGATION WAS NOT PROVIDED DESPITE SEVERAL REMINDERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.