BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON®-TB GOLD TEST

    MDR report key: 9824091 · Received March 12, 2020

    Report

    Report Number
    9824091
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 12, 2020
    Manufacturer
    QIAGEN
    Product Code
    NCD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPECIMEN DRAWN FOR (B)(6) TESTING. SPECIMEN WAS COLLECTED CORRECTLY IN ALL 4 TUBES, HOWEVER THERE WAS NO SERUM IN THE YELLOW AND GRAY TUBES AFTER THE SAMPLE WAS SPUN. THE GREEN AND PURPLE TUBES HAD SERUM. POSSIBLE ISSUE WITH THE YELLOW AND GRAY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285533 QUANTIFERON®-TB GOLD TEST TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS NCD QIAGEN 1083244 (YELLOW); GRAY

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA