BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1171491 · Received September 17, 2008

    Report

    Report Number
    2919069-2008-00697
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Removal / Correction Number
    2919069-12/1/09-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI