BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QBC STAR

    MDR report key: 347765 · Received August 10, 2001

    Report

    Report Number
    MW1022656
    Event Type
    Malfunction
    Date Received
    August 10, 2001
    Date of Event
    July 1, 2000
    Report Date
    August 6, 2001
    Manufacturer
    BD
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVIEWED PHONE LOGS FROM QBC STAR MFR STATING THIS ANALYZER WAS REPLACED BY MFR 5 TIMES FROM 2000-2001, WHEN OPERATORS COULD NOT PRODUCE CBC RESULTS. WHEN MFR REPS WERE ON-SITE TO PROVIDE TRAINING AND TROUBLESHOOTING, DIFFERING REPS GAVE CONFLICTING SPECIMEN MIXING INSTRUCTIONS. LAB STAFF UNABLE TO PERFORM TESTING, THEREFORE CLINICIANS HAVE TO WAIT FOR REFERENCE LAB RESULTS. DELAY IN TESTING TIME IMPACTS PT'S CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36453 QBC STAR CBC ANALYZER GKZ BD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other