BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON JUNIOR

    MDR report key: 558610 · Received November 23, 2004

    Report

    Report Number
    558610
    Event Type
    Other
    Date Received
    November 23, 2004
    Date of Event
    August 10, 2004
    Report Date
    November 5, 2004
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT NOT GIVING ACCURATE READINGS. ADDITIONAL ACT'S, ACTIVATED CLOTTING TIME, WERE DRAWN OF 2 OTHER DEVICES TO VERIFY RESULTS. ELECTRIC AND WET QC'S, QUALITY CHECKS, CHECK OUT FINE, BUT THE ACTUAL TEST RESULTS ARE INACCURATE. MANUFACTURER HAS GIVEN FACILITY A BACK-UP FOR EVERY UNIT AND RUNNING TWO TESTS FOR EACH SPECIMEN FOR VERIFICATION. THERE ARE 9 UNITS IN THE EP, ELECTROPHYSIOLOGY, LAB AND THEY ALL HAVE THE SAME LOT NUMBER. MANUFACTURER IS RESOLVING THE ISSUE, IF THEY CANNOT FACILITY WILL BE GETTING NEW UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JUNIOR ACT ANALYZER JBP INTERNATIONAL TECHNIDYNE CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR