TINA-QUANT HBALC GEN. 3

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS W/O ISE. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023, THE INITIAL RESULT FROM THE ANALYZER WAS 8.49 %. THE FIRST REPEAT RESULT FROM THE C 513 WAS 7.47 %. THE SECOND REPEAT RESULT FROM THE C 513 WAS 7.50 %. ON (B)(6) 2023, THE THIRD REPEAT RESULT FROM THE ANALYZER WAS 7.51 %. THE FOURTH REPEAT RESULT FROM THE C 513 WAS 7.43 %.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS INTEGRA 400 PLUS W/O ISE IS (B)(6). THE INVESTIGATION NOTED THAT THE CUSTOMER ONLY CALIBRATES ON "EVERY LOT" AND WHEN QC REQUIRES RECALIBRATION. PRODUCT LABELING STATES "CALIBRATION FREQUENCY HB AND HBA1C: FULL CALIBRATION IS RECOMMENDED. - AFTER 29 DAYS DURING SHELF LIFE. - AFTER REAGENT LOT CHANGE. - AS REQUIRED FOLLOWING QC PROCEDURES." BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CAUSED BY THE CUSTOMER'S INCORRECT CALIBRATION AND AN UNDETERMINED CAUSE.