TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

ON (B)(6) 2023 A MECHANISM CHECK WAS PERFORMED WITH ACCEPTABLE RESULTS. THE GEAR PUMP PRESSURE, CELL RINSE TUBING, AND CELL COVER WERE ALL ACCEPTABLE. IT WAS NOTED THAT THE SAMPLE PROBE RINSE STATION HAD BLOOD STAINS. PRECISION RESULTS AND QC WERE ACCEPTABLE. "ABNORMAL ASPIRATION", "SAMPLE DUPLICATION" AND "CLOT DETECTION" ERRORS WERE OBSERVED ON THE ALARM TRACE DATA. THE PHOTOMETER LAMP WAS LAST REPLACED ON (B)(6) 2023. THE SAMPLE PROBE WAS LAST REPLACED AND ADJUSTED ON (B)(6) 2023. CELLS WERE LAST REPLACED ON (B)(6) 2023. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH SAMPLE QUALITY ISSUES OR CONTAMINATION OF THE SAMPLE PROBE.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT HBA1C GEN. 3 (HBA1C) ON A COBAS 8000 C 502 MODULE. THE INITIAL RESULT FROM THE C502 MODULE WAS 7.89%. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR COMPLAINED AS THE PATIENT HAD AN HBA1C OF 5.7% ON AN UNSPECIFIED POINT-OF-CARE INSTRUMENT. ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON THE C502 MODULE WITH A RESULT OF 5.66%. THE C502 MODULE SERIAL NUMBER WAS (B)(4).