TINA-QUANT IGA GEN.2

Additional Manufacturer Narrative

SECTION D4 EXPIRATION DATE WAS UPDATED. THE PATIENT SAMPLE COULD POSSIBLY HAVE A VERY HIGH IGA CONCENTRATION. BASED ON THE AVAILABLE DATA AND THE OBSERVED FAILURE MODE, THERE WAS NO EVIDENCE OF AN INSTRUMENT OR A REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGA GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7682 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING A DECREASED SAMPLE VOLUME AND THE RESULT WAS 7646 MG/DL WITH A DATA FLAG. THE OPERATOR QUESTIONED THE RESULTS, AS THEY WERE ABOVE THE ASSAY MEASURING RANGE, AND THE SAMPLE WAS REPEATED. ON (B)(6) 2024 THE REPEATED RESULT WITH A 1:3 DILUTION WAS 24.6 MG/DL. THE SAMPLE WAS REPEATED AND THE RESULT WAS 28971 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING A DECREASED SAMPLE VOLUME AND THE RESULT WAS 7443 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING AN INCREASED SAMPLE VOLUME AND THE RESULT WAS 5.16 MG/DL. ON (B)(6) 2024 THE SAMPLE WAS REPEATED WITH A MANUAL DILUTION (1:2 RATIO) AND THE RESULT WAS 8884 MG/DL WITH A DATA FLAG. THE RAW VALUE, THAT WAS MEASURED WHEN USING A DECREASED SAMPLE VOLUME, WAS 3777 MG/DL. THE FINAL VALUE WHEN APPLYING THE DILUTION FACTOR WAS 7554 MG/DL.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.