TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COMPLAINED C513 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SEVEN PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE CUSTOMER NOTICED A POSITIVE BIAS IN PATIENT HBA1C RESULTS AND REPEATED THESE USING AN HPLC METHOD AND A SECOND C513 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.50 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 4.80 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.20 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.70 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 5.00 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.50 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.30 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 4.70 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.00 %. THE FOURTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.80 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 6.20 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 6.60 %. THE FIFTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.60 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 5.00 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.40 %. THE SIXTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.70 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 4.90 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.40 %. THE SEVENTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.70 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 5.10 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.50 %.

Additional Manufacturer Narrative

THE CENTRAL PROCESSING UNIT (CPU) OF THE ANALYZER WAS REPLACED WITH THE CPU OF A SECOND ANALYZER. ALL DATA FROM THE COMPLAINED ANALYZER WAS DELETED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.