TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE LINE WAS DIRTY. THE FSE REPLACED THE SAMPLE PROBE AND CLEANED THE SAMPLE LINE. OPERATIONAL AND MECHANICAL CHECKS WERE PERFORMED SUCCESSFULLY. THE CUSTOMER PERFORMED QC SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER HAD BEEN HAVING PREVIOUS TEST ISSUES AND DECIDED TO REPEAT THE PATIENT SAMPLES. FOR PATIENT 1, THE INITIAL A1C RESULT WAS 8.6%. THE REPEAT RESULT WAS 5.2%. FOR PATIENT 2, THE INITIAL A1C RESULT WAS 9.1%. THE REPEAT RESULT WAS 6.39%. FOR PATIENT 3, THE INITIAL A1C RESULT WAS 9%. THE REPEAT RESULT WAS 6.33%. FOR PATIENT 4, THE INITIAL A1C RESULT WAS 8.5%. THE REPEAT RESULT WAS 5.7%. THE REPEAT RESULTS WERE DEEMED CORRECT.