TINA-QUANT HBALC GEN. 3

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENTS' WHOLE BLOOD SAMPLES TESTED WITH THE HBA1C ON A COBAS 8000 CORE UNIT. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 13.5%. REPEAT RESULT: 6.4%. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 12.4%. REPEAT RESULT: 6.8%. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 8.4%. REPEAT RESULT: 7.5%. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' MEDICAL HISTORY AND THE SAMPLES WERE THEN REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

THE HBA1C REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6). QC WAS WITHIN RANGE ON THE DAY OF THE EVENT BUT DRIFTING HIGH ON THE HIGHER CONTROL. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND FOUND NO ISSUE. HE PERFORMED AN INSTRUMENT CHECK AND PRECISION STUDIES AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.