TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

MEDWATCH FIELDS D1 TO D3 UPDATED. THE INVESTIGATION REVIEWED THE CALIBRATION RECOVERY. THE CALIBRATION RECOVERY WAS ONLY PROVIDED FOR THE HEMOGLOBIN (HB) PORTION OF THE ASSAY AND DID NOT CONTAIN CALIBRATION RECOVERY PRIOR TO THE EVENT. THE INVESTIGATION REVIEWED THE QC RECOVERY. ONLY THE CUMULATIVE QC STATISTICS INFORMATION WAS PROVIDED. INDIVIDUAL QC RESULTS WERE NOT PROVIDED. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE ALARM TRACE; NO ISSUES WERE NOTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND FOUND NO CAUSE FOR THE ISSUE. HE NOTED THAT THE ANALYZER WAS WORKING WITHIN SPECIFICATION. HE PERFORMED INSTRUMENT CHECKS WITH SUCCESSFUL RESULTS. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE REAGENT LOT NUMBER IS 665197. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLEA1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C513 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTICED A POSITIVE BIAS ON THE ANALYZER WHEN THEY COMPARED THE RESULTS OF THE PATIENT SAMPLE. THE PATIENT STATED THAT THERE WERE TWO SAMPLES FROM THE PATIENT - SAMPLE 1 AND SAMPLE 2. THE INITIAL RESULT OF SAMPLE 1 FROM ANALYZER 2 WAS 6.3%. THE REPEAT RESULT OF SAMPLE 1 FROM ANALYZER 1 WAS 6.9% THE REPORTER PERFORMED TROUBLESHOOTING AND RAN BOTH SAMPLES ON ANALYZER 1 AND ANOTHER ANALYZER (ANALYZER 3). THE RESULTS OF SAMPLE 1 AND SAMPLE 2 FROM ANALYZER 1 WERE BOTH 6.3%. THE RESULTS OF SAMPLE 1 AND SAMPLE 2 FROM ANALYZER 3 WERE BOTH 6.6%. THE RESULT FROM ANALYZER 2 WAS DEEMED CORRECT.