BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2250051-2008-00337

    MDR report key: 1180623 · Received July 18, 2008

    Report

    Report Number
    2250051-2008-00337
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE E AND FYA ANTIGENS. RESULTS WERE SATISFACTORY. THE PT SAMPLE WAS RETURNED FOR TESTING. ALTHOUGH VRA116 WAS EXPIRED, THE RETURNED PT SAMPLE WAS TESTED WITH VARIOUS IN-DATE E+ FYA- REAGENT RED CELLS. WEAK REACTIVITY (0.5+) WAS OBSERVED WITH 1/3 CELLS AFTER A 4-MINUTE INCUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KSZ

    Patients

    Seq Age Sex Outcome Treatment
    1