BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT APOLIPOPROTEIN A-1 VER.2

    MDR report key: 19972879 · Received August 13, 2024

    Report

    Report Number
    1823260-2024-02347
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DER
    UDI-DI
    07613336133521
    PMA / PMN Number
    K013249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QC WAS WITHIN THE ACCEPTABLE RANGE. NO ISSUES WERE IDENTIFIED WITH THE CUSTOMER'S CURRENT CALIBRATION. MANY SAMPLE SHORT ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EVENT IS CONSISTENT WITH AN ISSUE WITH THE SAMPLE PROBE DUE TO PREANALYTICAL HANDLING ISSUES AND/OR INSUFFICIENT PROBE WASH. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (APOAT) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.489 G/L. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD AND THE RESULT WAS "DISCREPANT." THE SPECIFIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED ON THE C503 ANALYZER USING A 1:2 DILUTION AND THE RESULT WAS 0.85 G/L. A NEW SAMPLE WAS OBTAINED AND THE INITIAL RESULT ON THE C503 ANALYZER WAS 0.8 G/L. THE SAMPLE WAS REPEATED USING A 1:2 DILUTION AND THE RESULT WAS 0.924 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200961 TINA-QUANT APOLIPOPROTEIN A-1 VER.2 ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM DER ROCHE DIAGNOSTICS ASKU 07613336133521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown