BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2BACTERIA PANEL

    MDR report key: 19882662 · Received August 1, 2024

    Report

    Report Number
    3010097867-2024-00008
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Report Date
    August 1, 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

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE COLLECTION OF THE WHOLE BLOOD SAMPLE USED TO RUN THE T2BACTERIA PANEL MAY NOT ALWAYS OCCUR CONCURRENTLY WITH BLOOD CULTURE SAMPLE COLLECTION, AND THAT ANTIBIOTIC THERAPY MAY HAVE BEEN INITIATED AFTER BLOOD CULTURE COLLECTION BUT PRIOR TO COLLECTION OF T2BACTERIA PANEL SAMPLE.

    Description of Event or Problem · 0

    T2BIOSYSTEMS RECEVIVED INFORMATION FROM A CUSTOMER REPORTING HISTORICAL DATA WITH INSTANCES OF POTENTIAL FALSE NEGATIVE E. COLI RESULTS USING THE T2BACTERIA PANEL. INCIDENT RATE IS REPORTED AS AROUND 1% OF CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025317 T2BACTERIA PANEL DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM QBX T2 BIOSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown