TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE ISSUE WAS RESOLVED BY REPLACING THE REAGENT CASSETTE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULTS FOR 5 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS MODULE. FOR PATIENT (B)(6), THE INITIAL HBA1C RESULT WAS 12.21%. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 6.46%. FOR PATIENT (B)(6), THE INITIAL HBA1C RESULT WAS 11.95%. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 6.18%. FOR PATIENT (B)(6), THE INITIAL HBA1C RESULT WAS 11.63%. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 6.61%. FOR PATIENT (B)(6) , THE INITIAL HBA1C RESULT WAS 16.29%. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 12.11%. FOR PATIENT (B)(6) , THE INITIAL HBA1C RESULT WAS 12.56%. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 7.15%. THE CUSTOMER RECALIBRATED AND RERAN CONTROLS BEFORE REPEATING THE SAMPLES. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).