BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1171530 · Received September 17, 2008

    Report

    Report Number
    1628664-2008-00217
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI