BEUDAMED
    FDA Adverse Event Other Summary report: N

    QBC STAR

    MDR report key: 374143 · Received January 24, 2002

    Report

    Report Number
    MW1023912
    Event Type
    Other
    Date Received
    January 24, 2002
    Report Date
    January 16, 2002
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    GKZ
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS AUTOMATED CBC UNIT FAILS TO READ THE TESTS 15% OF THE TIME. THIS WAS SAID TO BE BETTER, MORE ACCURATE AND LESS EXPENSIVE THAN THE MANUAL QBC UNIT. THE TEST TUBES ARE MALFUNCTIONING DURING THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QBC STAR LAB EQUIPMENT BLOOD HEMOGRAM UNIT GKZ BECTON DICKINSON & CO. QBC STAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other