BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE TORCH GI PANEL

    MDR report key: 21492527 · Received February 28, 2025

    Report

    Report Number
    MW5167055
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 12, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BIONERIEUX / SA/BIORFIRE DIAGNOSTICS, LLC.
    Product Code
    PCH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE STOOL SAMPLE WAS DETECTED FOR SALMONELLA AND ROTAVIRUS ON BIOFIRE GASTRO INTESTINAL PANEL, BUT ONLY SALMONELLA WAS CONFIRMED ON VERIGENE AND ROTAVIRUS WAS NOT DETECTED ON VERIGENE ENTERIC PANEL. 28 YEARS OLD MALE PRESENTS FOR EVALUATION OF DIARRHEA FOR 01 WEEK. NO SICK CONTACTS RECENTLY. NO RECENT TRAVEL. PATIENT GENERALLY HEALTHY. NO SURGICAL HISTORY. PATIENT DENIES EATING ANY CONTAMINATED FOOD THAT HE KNOWS OF OR DRINKING CONTAMINATED LIQUIDS. NO RECENT CAMPING. NO BLOOD IN STOOLS. HE STATES HE IS HAVING SOMETIMES 02 BOWEL MOVEMENTS PER HOUR. HE IS NOT REALLY HAVING ABDOMINAL PAIN BUT DOES GET SOME CRAMPING WHEN HE HAS A BOWEL MOVEMENT COMING UP. "LOT NUMBER 2062224".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586487 BIOFIRE TORCH GI PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH BIONERIEUX / SA/BIORFIRE DIAGNOSTICS, LLC. GI PANEL V2.1 3HP324

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male