BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSOMAL ELISA

    MDR report key: 419957 · Received September 30, 2002

    Report

    Report Number
    MW1026326
    Event Type
    Malfunction
    Date Received
    September 30, 2002
    Date of Event
    September 18, 2002
    Report Date
    September 30, 2002
    Manufacturer
    WAMPOLE LABORATORIES
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TEST KIT PROVIDED WITH INCORRECT CONSTANTS FOR CALCULATION OF PT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSOMAL ELISA IN VITRO DIAGNOSTIC ASSAY JLW WAMPOLE LABORATORIES * 437970-033

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other