TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER ADJUSTED THE REAGENT PROBE AND PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER. NO FURTHER ISSUES OCCURRED AFTER THESE ACTIONS. THERE WAS NO INDICATION OF A GENERAL REAGENT PROBLEM. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C311 ANALYZER IS (B)(6). THE WATER TANK WAS CLEANED, THE CELLS WERE REPLACED, THE WATER PATH WAS CLEANED, AND MAINTENANCE WAS PERFORMED ON THE ANALYZER. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 5 PATIENT SAMPLES TESTED WITH TINA-QUANT HBALC GEN. 3 ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULTS WERE MEASURED USING TWO DIFFERENT LOTS OF HBA1C REAGENT IN COMPARISON TO RESULTS MEASURED WITH AN UNKNOWN COMPETITOR METHOD. THE FIRST SAMPLE RESULTED IN AN HBA1C VALUE OF 4.27 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 4.8 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.4 %. THE SECOND SAMPLE RESULTED IN AN HBA1C VALUE OF 4.49 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 5.08 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.3 %. THE THIRD SAMPLE RESULTED IN AN HBA1C VALUE OF 6.42 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 6.74 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 8.5 %. THE FOURTH SAMPLE RESULTED IN AN HBA1C VALUE OF 5.07 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 5.58 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.6 %. THE FIFTH SAMPLE RESULTED IN AN HBA1C VALUE OF 5.04 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 5.62 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.6 %. THE COMPETITOR RESULTS WERE REPORTED TO THE PATIENT. THE COMPETITOR RESULTS AND RESULTS MEASURED WITH LOT 736996 WERE MORE COMPATIBLE WITH THE HISTORY OF THE PATIENTS.