BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFIRE GI PANEL

    MDR report key: 9028916 · Received September 12, 2019

    Report

    Report Number
    MW5089772
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BIOFIRE DIAGNOSTICS, INC.
    Product Code
    PCH
    UDI-DI
    00815381020109
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE POSITIVE VIBRIO CHOLERA DETECTED AND REPORTED. PT WAS TRANSFERRED TO A NEW FACILITY AND ALSO PLACED ON TETRACYCLINE FOR VIBRIO INFECTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798796 BIOFIRE GI PANEL GASTROINTESTINAL PATHOGEN PANEL PCH BIOFIRE DIAGNOSTICS, INC. RFIT-ASY-0116 779519 00815381020109

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O