BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIMEDX FTA DS8400

    MDR report key: 874373 · Received June 27, 2007

    Report

    Report Number
    MW5002859
    Event Type
    Malfunction
    Date Received
    June 27, 2007
    Report Date
    June 26, 2007
    Manufacturer
    SCIMEDX
    Product Code
    GMQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCIMEDX FTA KIT APPEARS TO HAVE A LOT OF BACKGROUND, THE CONTROLS APPEAR TO RUN LOW AND THERE SEEM TO BE MANY PT'S COMING UP AS INCONCLUSIVE. THE PROBLEM HAS BEEN REPORTED TO THE VENDOR WITH NO APPARENT IMPROVEMENT. I UNDERSTAND THAT THERE WERE DISCUSSIONS WITH THE VENDOR WHO REPORTED THAT QUEST DIAGNOSTICS HAD A 50% POSITIVITY RATE. THIS SEEMS TO CROSS SEVERAL LOT NUMBERS AND HAS BEEN SEEN IN OUR LAB OVER THE LAST YEAR AT LEAST. DATES OF USE: YEARS. DIAGNOSIS: TESTING FOR IGG ANTIBODIES AGAINST SYPHILUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMEDX FTA DS8400 NONE GMQ SCIMEDX DS8400

    Patients

    Seq Age Sex Outcome Treatment
    1 YR