BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AUTOMATION SYSTEM

    MDR report key: 92055 · Received May 20, 1997

    Report

    Report Number
    MW1011326
    Event Type
    Other
    Date Received
    May 20, 1997
    Date of Event
    August 1, 1996
    Report Date
    May 20, 1997
    Manufacturer
    COULTER CORP.
    Product Code
    JQW
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE ALLOCATES THE SERUM INTO WRONG TUBES. THE SYSTEM HAS CAUSED WRONG RESULTS FOR DIGOXIN AND PREGNANCY TESTS. THE REPORTER HAS INFORMED THE FACILITY MANAGEMENT AND THE MFR BUT HAS NOT SEEN ANY ATTEMPTS TO SOLVE THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AUTOMATION SYSTEM BLOOD SAMPLE HANDLER JQW COULTER CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other