TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

BASED ON THE PROVIDED DATA AND OBSERVED FAILURE MODE, THERE IS NO EVIDENCE OF AN INSTRUMENT AND REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH DIFFERENCES IN TRACEABILITY AND STANDARDIZATION OF THE METHODS.

Additional Manufacturer Narrative

THE HBA1C REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS PURE C303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE CUSTOMER MENTIONED THAT THEY HAD QC ISSUES. THE CALIBRATION VALUE WAS HIGHER THAN THE PREVIOUS CALIBRATION VALUE. THE FIELD APPLICATION SPECIALIST REQUESTED A REAGENT REPLACEMENT, AND RECALIBRATION AND QC RETESTING AND THE RESULTS WERE SUCCESSFUL. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH THE HBA1C ON A COBAS PURE C303 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT SYSTEM. INITIAL RESULT: 6.53 %. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 5.9 % (TESTED ON ANOTHER SYSTEM). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.