BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE JOINT INFECTION PANEL

    MDR report key: 25302223 · Received May 27, 2026

    Report

    Report Number
    3002773840-2026-00013
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    November 28, 2025
    Report Date
    May 27, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QSN
    UDI-DI
    00815381020192
    PMA / PMN Number
    DEN200066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ANALYSE BIOLAB GMBH ((B)(6), AUSTRIA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS (S. AUREUS) RESULT ON THE BIOFIRE JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE JI PANEL RESULT, THE PATIENT UNDERWENT A REPEAT JOINT ASPIRATION. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. SIMILAR EVENTS WERE RECENTLY OBSERVED IN THE FIELD WITH FALSE POSITIVE STAPHYLOCOCCUS AUREUS ON THE BIOFIRE JOINT INFECTION (JI) PANEL LOTS 0878825 AND 0883425. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED IN THE U.S. ON (B)(6) 2026 VIA FSCA FA-TWD-000074.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236828 BIOFIRE JOINT INFECTION PANEL BIOFIRE JOINT INFECTION PANEL QSN BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0138 0878825 00815381020192

    Patients

    Seq Age Sex Outcome Treatment
    1