BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS

    MDR report key: 555494 · Received November 25, 2003

    Report

    Report Number
    555494
    Event Type
    Malfunction
    Date Received
    November 25, 2003
    Date of Event
    July 21, 2003
    Report Date
    September 26, 2003
    Manufacturer
    ORTHO CLINICAL DIAGNOSIS / JOHNSON JOHNSON COMPANY
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY INSTRUMENT X 2 JJE ORTHO CLINICAL DIAGNOSIS / JOHNSON JOHNSON COMPANY VITROS 250 AND VITROS 950 REAGENT 0333-0317-6336 EX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR