TINA-QUANT HEMOGLOBIN A1CDX GEN.3

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT QUALITY CONTROLS WERE WITHIN RANGE. A ROCHE FIELD APPLICATION SPECIALIST VISITED THE SITE AND DETERMINED THAT THE CUSTOMER'S CONTROL RANGES WERE TOO LARGE AND THAT THE RANGES SHOULD BE TIGHTENED IN ORDER TO DETECT SHIFTS. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THE HBA1C REAGENT LOT NUMBER WAS 821679. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.4 %. A DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 5.7 % AND THIS VALUE WAS DEEMED CORRECT.