BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT IGA GEN.2

    MDR report key: 19807374 · Received July 23, 2024

    Report

    Report Number
    1823260-2024-02119
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 21, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CZP
    UDI-DI
    07613336121313
    PMA / PMN Number
    K040435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936058 TINA-QUANT IGA GEN.2 IMMUNOGLOBULIN A CZP ROCHE DIAGNOSTICS 716674 07613336121313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female