HBA1C TQ GEN.3

Additional Manufacturer Narrative

DATA WAS REQUESTED FOR INVESTIGATION BUT NOT PROVIDED DESPITE SEVERAL REMINDERS WITHIN MORE THAN 3 MONTHS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS C111 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 7 PATIENTS' SAMPLES TESTED WITH HBA1C ASSAY ON A COBAS C111 ANALYZER. SAMPLE 1 AND SAMPLE 2 WERE REPEATED ON (B)(6) 2024: SAMPLE 1 (PATIENT 1): INITIAL RESULT: 7.6 %. REPEAT RESULT: 5.8 %. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 8.9 %. REPEAT RESULT: 6.5 %. SAMPLE 3 (PATIENT 3) WAS REPEATED ON (B)(6) 2024: INITIAL RESULT: 7.0 %. REPEAT RESULT: 5.4 %. SAMPLE 4, SAMPLE 5, SAMPLE 6, AND SAMPLE 7 WERE REPEATED ON (B)(6) 2024: SAMPLE 4 (PATIENT 4): INITIAL RESULT: 6.7 %. REPEAT RESULT: 5.2 %. SAMPLE 5 (PATIENT 5): INITIAL RESULT: 8.8 %. REPEAT RESULT: 6.7 %. SAMPLE 6 (PATIENT 6): INITIAL RESULT: 9.4 %. REPEAT RESULT: 7.4 %. SAMPLE 7 (PATIENT 7): INITIAL RESULT: 6.6 %. REPEAT RESULT: 5.2 %. THE PATIENTS QUESTIONED THEIR INITIAL RESULTS AND, THEREFORE, THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.