HBA1C III TINA-QUANT HEMOGLOBIN A1C III

Additional Manufacturer Narrative

UPON REVIEW OF THE CALIBRATION DATA, FREQUENT SENSITIVITY ERRORS WERE OBSERVED AND THIS IS ABNORMAL. THIS ALARM IS INDICATED IF THE SENSITIVITY VALUE OBTAINED IN A CALIBRATION FALLS OUT OF THE SENSITIVITY LIMITS SPECIFIED IN THE ANALYZER SETTINGS FOR THE TEST. UPON REVIEW OF CONTROL DATA, HIGH IMPRECISION WAS OBSERVED. THE INSTRUMENT IS NOT PERFORMING AS EXPECTED. BASED ON ALARM TRACE INFORMATION, THE CUSTOMER MAINTENANCE IS NOT BEING PERFORMED ACCORDING TO INSTRUCTIONS. THE SAMPLE PROBE WAS BENT AND THIS WAS DETERMINED TO BE THE ROOT CAUSE OF THE ISSUE.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 4000 C (311) STAND ALONE SYSTEM. THE SAMPLE RESULTED WITH AN HBA1C VALUE OF 4.1 % WHEN TESTED ON THE CUSTOMER'S C 311 ANALYZER AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN METHOD, RESULTING WITH AN HBA1C VALUE OF 6.2 %. ALL MEASUREMENTS PERFORMED ON THE C 311 ANALYZER REPEAT WITH THE SAME VALUE INITIALLY OBTAINED ON THE C 311 ANALYZER. THE SERIAL NUMBER OF THE CUSTOMER'S C 311 ANALYZER IS (B)(4).