BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF AL

    MDR report key: 1760322 · Received July 16, 2010

    Report

    Report Number
    1061932-2010-00079
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    April 6, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CF WAS GENERATED INTERNALLY BY BCI. NO CLEAR ROOTS CAUSE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THERE IS A REMOTE POSSIBILITY FOR THE ACT 5DIFF SERIES INSTRUMENT TO GENERATE ERRONEOUS YET CREDIBLE RESULT IF A TOTAL FAILURE OCCURS IN ONE OR MULTIPLE VALVES FOR ANY OF THE PARAMETERS. THERE WAS NO EFFECT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF AL HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. ACT 5DIFF AL

    Patients

    Seq Age Sex Outcome Treatment
    1