BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2BACTERIA PANEL

    MDR report key: 20239756 · Received September 17, 2024

    Report

    Report Number
    3010097867-2024-00028
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 17, 2024
    Manufacturer
    T2 BIOSYSTEMS, INC.
    Product Code
    QBX
    PMA / PMN Number
    K233184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    19 AUGUST 2024: T2BIOSYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE S. AUREUS RESULT USING THE T2BACTERIA PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463951 T2BACTERIA PANEL DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM QBX T2 BIOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other