TINA-QUANT HEMOGLOBIN A1CDX GEN.3

Additional Manufacturer Narrative

THE ALARM TRACE DATA INDICATED AN ISSUE WITH THE SAMPLE PROBES. QUALITY CONTROL DATA SHOWED HIGH RESULTS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER STATED THAT DOCTORS ARE COMPLAINING OF HIGHER PATIENT RESULTS COMPARED TO THEIR PREVIOUS BIORAD (D-10) METHOD. THE CUSTOMER PROVIDED A HYPOTHETICAL SCENARIO OR A PATIENT SAMPLE HBA1C VALUE INITIALLY RECOVERING AS 6.0 % AND REPEATING AS 8.0 %. THE CUSTOMER PROVIDED SPECIFIC DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT HBA1C RESULTS. THE PATIENT SAMPLE RESULTED IN AN HBA1C VALUE OF 8.5 % WITH A DATA FLAG (EXPECTED RANGE = 4.0 % 6.0 %) WHEN TESTED ON THE C 503 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED USING THE BIORAD D-10 METHOD, RESULTING IN AN HBA1C VALUE OF 7.2 % (EXPECTED RANGE = 4.8 % - 5.9 %) .

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.