BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN WBC REAGENT A

    MDR report key: 1171499 · Received September 17, 2008

    Report

    Report Number
    2919069-2008-00698
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K961439
    Removal / Correction Number
    2919069-1/3/08-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN WBC REAGENT A WBC REAGENT A GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI