BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TB QUANTIFERON GOLD

    MDR report key: 1327254 · Received February 24, 2009

    Report

    Report Number
    MW5010079
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 24, 2009
    Product Code
    GRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TB QUANITFERON TEST REPORTED POSITIVE ON THE ABOVE DATE. DUE TO INCREASE IN THE NUMBER OF FALSE POSITIVES WITH THIS TEST THROUGH QUEST DIAGNOSTICS, IT WAS REPEATED IN 2009, AND WAS REPORTED UNLIKELY ON THE SECOND TEST. DIAGNOSIS OR REASON FOR USE: HIV INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TB QUANTIFERON GOLD NONE GRT

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR