TINA-QUANT HBALC GEN. 3

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR TINA-QUANT HBA1C GEN. 3 (HBA1C) ON A COBAS 8000 C 502 MODULE. (B)(6) 2023 PATIENT 1 INITIAL RESULT WAS 87.45%. THE SAMPLE WAS REPEATED AS THIS RESULT WAS BELIEVED TO BE TOO HIGH. THE REPEAT RESULT WAS 52.26%. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER MODULE WITH A RESULT OF 67.65%. ON (B)(6) 2023 PATIENT 2 INITIAL RESULT WAS 8.3%. THE REPEAT RESULT WAS 5.0%.

Additional Manufacturer Narrative

THE C502 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. MAINTENANCE IS REGULARLY PERFORMED BY THE CUSTOMER. THE INSTRUMENT CUVETTES AND LAMPS WERE REPLACED ON (B)(6) 2023. FREQUENT SAMPLE PROBE "ABNORMAL ASPIRATION" ALARMS WERE OBSERVED ON THE ALARM TRACE. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

FOR PATIENT 1, THE RESULTS WERE REPRESENTING VALUES IN MMOL/MOL, HOWEVER, THE CUSTOMER HAD CHANGED THE SETTINGS ON THE INSTRUMENT TO READ IN % UNIT OF MEASURE. FOR BOTH PATIENTS, THE LOWER RESULTS WERE BELIEVED TO BE CORRECT. THE FIELD SERVICE ENGINEER (FSE) DID NOT IDENTIFY ANY TECHNICAL ISSUES. THE CUSTOMER HAS NOT HAD ANY FURTHER ISSUES WITH QUESTIONABLE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE EXPECTED VALUE FOR PATIENT 2 WAS 5.1 %.