BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2BACTERIA PANEL

    MDR report key: 19922627 · Received August 6, 2024

    Report

    Report Number
    3010097867-2024-00018
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    May 2, 2024
    Report Date
    August 6, 2024
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QBX
    UDI-DI
    M70880073423
    PMA / PMN Number
    K233184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT OF A CLINICAL FALSE POSITIVE K. PNEUMONIAE RESULT USING THE T2 BACTERIA PANEL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560273 T2BACTERIA PANEL DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM QBX T2 BIOSYSTEMS, INC T2BACTERIA PANEL WO-23374 M70880073423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown