BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTIFERON

    MDR report key: 19132630 · Received April 18, 2024

    Report

    Report Number
    1122376-2024-00001
    Event Type
    Injury
    Date Received
    April 18, 2024
    Report Date
    April 18, 2024
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NCD
    UDI-DI
    04053228015864
    PMA / PMN Number
    P010033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CLAIM HARM RESULTING FROM TREATEMENT FOR POSIITIVE QFT PLUS AND PPD RESULTS. INSUFFICIENT INFORMATION WAS PROVIDED FOR A COMPREHENSIVE INVESTIGATION. AS STATED IN THE IFU, QFT-PLUS IS AN INDIRECT TEST FOR M. TUBERCULOSIS INFECTION (INCLUDING DISEASE) AND IS INTENDED FOR USE IN CONJUCTION WITH RISK ASSESSMENT, RADIOGRAPHY AND OTHER MEDICAL AND DIAGNOSTIC EVALUATIONS.

    Description of Event or Problem · 0

    ALLEGED FALSE POSITIVE WITH QUANTIFERON TB PLUS ELISA, LEADING TO UNNECESSARY TREATMENT AND SERIOUS MEDICAL CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512402 QUANTIFERON QUANTIFERON TB PLUS ELISA NCD QIAGEN SCIENCES, LLC 04053228015864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other