BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2BACTERIA PANEL

    MDR report key: 20188928 · Received September 11, 2024

    Report

    Report Number
    3010097867-2024-00027
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QBX
    UDI-DI
    M70880073423
    PMA / PMN Number
    K233184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF THE DATA, THERE DO NOT APPEAR TO BE ANY ISSUES ATTRIBUTABLE TO CONTAMINATION OR HANDLING.

    Description of Event or Problem · 0

    (B)(6) 2024: T2 BIOYSTEMS RECEIVED A CUSTOMER COMPLAINT THAT THE T2BACTERIA PANEL PRODUCED A DISCORDANT RESULT. THE T2BACTERIA PANEL PRODUCED A POSITIVE P. AERUGINOSA RESULT COMPARED TO POSITIVE BLOOD CULTURE AND URINE CULTURE RESULTS FOR S. AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510918 T2BACTERIA PANEL DIRECT BLOOD BACTERIAL NUCLEIC ACID DETECTION SYSTEM QBX T2 BIOSYSTEMS, INC T2BACTERIA PANEL WO-23694 M70880073423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown