BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE JOINT INFECTION PANEL

    MDR report key: 25279365 · Received May 26, 2026

    Report

    Report Number
    3002773840-2026-00012
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QSN
    UDI-DI
    00815381020192
    PMA / PMN Number
    DEN200066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUMMARY: (B)(6) HOSPITAL (B)(6) (B)(6) REPORTED A POTENTIAL FALSE POSITIVE RESULT ON THE BIOFIRE JOINT INFECTION PANEL (JI) PANEL AFTER TESTING A PATIENT'S SYNOVIAL FLUID (SF). THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RESULT THE PATIENT WAS TREATED WITH ANTI-STAPHYLOCOCCAL ANTIBIOTICS. THE PATIENT¿S CONDITION WAS MOST LIKELY ATTRIBUTABLE TO A POSTOPERATIVE HEMATOMA. THE ANTIBIOTIC TREATMENT WAS MAINTAINED EMPIRICALLY DUE TO THE TKA-RELATED COMPLICATION. NO PATIENT HARM WAS REPORTED. 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 JI PANEL KIT LOTS 0878825 AND 0883425 HAVING AN ELEVATED RISK FOR FALSE POSITIVE STAPHYLOCOCCUS AUREUS. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED ON (B)(6) 2026, VIA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492410 BIOFIRE JOINT INFECTION PANEL BIOFIRE JOINT INFECTION PANEL QSN BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0138 0883425 00815381020192

    Patients

    Seq Age Sex Outcome Treatment
    1