BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1210549 · Received July 24, 2008

    Report

    Report Number
    2250051-2008-00304
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING. THE RESULTS WERE SATISFACTORY. THE CUSTOMER DID NOT FOLLOW THE IFU FOR WEAK D TESTING, WHERE THE TESTING SHOULD HAVE BEEN CONDUCTED IN TUBE AND NOT GEL. THE CUSTOMER PERFORMED WEAK D IN MANUAL GEL AS PER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1