BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON®-TB GOLD PLUS

    MDR report key: 23389720 · Received October 27, 2025

    Report

    Report Number
    23389720
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 8, 2025
    Manufacturer
    QIAGEN SCIENCES LLC
    Product Code
    NCD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD BLOOD DRAW FOR TB [TUBERCULOSIS] GOLD-QUANTIFERON LABS. NURSES WERE AWARE TO TAKE FULL TUBES FOR SAMPLE. SAMPLE WAS TAKEN TO LABORATORY, AND AFTER 2 DAYS THE LABORATORY DETERMINED THERE WAS NOT ENOUGH AMOUNT TO PROCESS THE SAMPLE. SECOND SAMPLE FROM SAME LOT HAD SAME RESULT, FAILURE TO FILL USING STANDARD "BUTTERFLY" NEEDLE SET. MANUFACTURER RESPONSE FOR BLOOD COLLECTION TUBES, QUANTIFERON - TB GOLD PLUS (QFT - PLUS) (PER SITE REPORTER). NOTIFIED VIA EMAIL ON [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734887 QUANTIFERON®-TB GOLD PLUS TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS NCD QIAGEN SCIENCES LLC 1 58105304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other