TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

H6 INVESTIGATION FINDINGS AND H6 INVESTIGATION CONCLUSION CODES UPDATED.

Additional Manufacturer Narrative

THE C303 ANALYZER SERIAL NUMBER WAS (B)(6) . THE INVESTIGATION FOUND NO ISSUES WITH THE CURRENT CALIBRATION. THE INVESTIGATION REVIEWED THE ALARM TRACE. THERE WERE SEVERAL "ABNORMAL ASPIRATION" ERRORS FOR THE SAMPLE PROBE. THE INVESTIGATION REVIEWED THE QC DATA; THERE WERE OUT-OF-RANGE (LOW) QC RESULTS FOR BOTH LEVELS; THERE WERE NO OUT-OF-RANGE RESULTS SINCE (B)(6) 2024. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE A1CX3 (HBA1C) RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR TEN PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE REPORTER COMPLAINED THAT HEALTHY PATIENTS HAD BORDERLINE TO NORMAL OR TOO HIGH HBA1C RESULTS. THE HEALTHY PATIENTS REPORTEDLY HAD RESULTS OF 5.8% TO 6.4%. NO REPEAT OR ADDITIONAL RESULTS WERE PROVIDED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL EVENT DETAILS.