TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE PROBE WAS PARTIALLY CLOGGED. THE PROBE WAS REMOVED, MANUALLY CLEANED, AND REINSTALLED. THE CUSTOMER CHECKED THE INSTRUMENT AND HAD NO FURTHER ISSUES RELATED TO HBA1C RESULTS. THE INVESTIGATION DETERMINED THAT SINCE THE SAMPLE PROBE WAS FOUND TO BE PARTIALLY CLOGGED, THE EVENT IS CONSISTENT WITH A GENERAL PREANALYTICAL ISSUE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FROM THE COBAS 6000 C501 MODULE. PATIENT 1 INITIAL RESULT WAS 6.0 %. ON (B)(6) 2025, THE RESULT FROM AN AFINION HBA1C ANALYZER WAS 5.4 %. ON (B)(6) 2025, PATENT 2 INITIAL RESULT WAS 5.8 %. THE RESULT FROM AN AFINION HBA1C ANALYZER WAS 4.9 %. ONE GENERAL EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 7 % AND A RESULT FROM AN AFINION HBA1C ANALYZER OF 5.8 %.

Additional Manufacturer Narrative

THE COBAS 6000 C501 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.