BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD3200SL 110

    MDR report key: 1171497 · Received September 17, 2008

    Report

    Report Number
    2919069-2008-00704
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200SL 110 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI