BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN-COULTER ANALYZER

    MDR report key: 1202341 · Received October 15, 2008

    Report

    Report Number
    MW5008648
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN-COULTER
    Product Code
    GKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT FAILURE OF BECKMAN-COULTER BLOOD ANALYZER RESULTING IN DILUTION -AND ERRONEOUS TEST RESULTS OF BLOOD SPECIMENS SUBMITTED IN PARTIALLY-FULL VACUTAINER TUBES. ADMITTED FOR WORK UP 2008. DISCHARGED WHEN FIRST FOLLOW UP CBC RETURNED WNL. DID NOT RECEIVE TREATMENT OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN-COULTER ANALYZER ANALYZER GKZ BECKMAN-COULTER LH1500 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization