TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER REPLACED THE LAMP AND CLEANED ALL LIGHT AND CUVETTE PATHS. THE WORK STATIONS AND MIXING MECHANISMS WERE CHECKED. CALIBRATIONS WERE PERFORMED AND WERE ACCEPTABLE. FOLLOWING CALIBRATION, PRECISION ISSUES WERE IMPROVED. CONTROLS WERE RUN AND THE RESULTS WERE ACCEPTABLE. THE SERVICE ENGINEER INDICATED THE LAMP WAS UNSTABLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH INSUFFICIENT CUSTOMER MAINTENANCE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE INTEGRA 400 PLUS ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER OBSERVED THAT THE WASHING TOWER HAD AN UNUSUAL OVERFLOW OF DROPLETS DURING THE WASHING PROCESS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HBALC GEN. 3 ON A COBAS INTEGRA 400 PLUS. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.52 % AND IT REPEATED AS 7.33 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 14.02 % WITH A DATA FLAG AND IT REPEATED AS 12.48 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.93 % ON (B)(6) 2024 AND IT REPEATED AS 7.5 %.