BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE JOINT INFECTION (JI) PANEL

    MDR report key: 24760769 · Received April 1, 2026

    Report

    Report Number
    3002773840-2026-00005
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    October 4, 2025
    Report Date
    April 1, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QSN
    UDI-DI
    00815381020192
    PMA / PMN Number
    DEN200066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE (B)(6) MEDICAL CENTER, (B)(6) REPORTED A POTENTIAL FALSE-POSITIVE S. AUREUS RESULT ON THE BIOFIRE JOINT INFECTION (JI) PANEL DURING PATIENT TESTING. THE PATIENT IS A 46-YEAR-OLD FEMALE WHO PRESENTED WITH RIGHT KNEE SWELLING AT THE TIME OF TESTING. ON (B)(6) 2025, SYNOVIAL FLUID WAS COLLECTED FROM THE PATIENT AND TESTED ON THE JI PANEL. ON (B)(6) 2025, THE JI PANEL REPORTED A 'DETECTED' RESULT FOR S. AUREUS. CULTURE YIELDED NO GROWTH AFTER FOUR DAYS, AND NO ORGANISM WAS SEEN ON GRAM STAIN. ON (B)(6) 2025, REPEAT TESTING WAS PERFORMED USING THE JI PANEL, AND A 'NOT DETECTED' RESULT FOR ALL ANALYTES WAS REPORTED. THE RESULTS REPORTED TO THE PHYSICIAN WERE S. AUREUS DETECTED. THE PATIENT WAS NOT NEGATIVELY IMPACTED BY THE RESULT AND WAS DISCHARGED WITH MEDICINE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S FINAL DIAGNOSIS WAS RIGHT KNEE EFFUSION. THE ANALYSIS OF THE JI PANEL RUN FILES PROVIDED BY THE CUSTOMER SHOWED LATE OR NO AMPLIFICATION SUGGESTING THAT THE TARGET NUCLEIC ACID WAS PRESENT AT LOW LEVELS. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. AN IN-HOUSE INVESTIGATION WAS PERFORMED ON THE JI PANEL POUCH LOT AND CONCLUDED POTENTIAL REAGENT POUCH CONTAMINATION DURING MANUFACTURING OF THE LOT. CONCLUSION: THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS DUE TO CONTAMINATION DURING MANUFACTURING. ANALYSIS OF THE CUSTOMER PROVIDED INFORMATION AND IN-HOUSE INVESTIGATION OF THE BIOFIRE JI PANEL POUCH LOT INDICATE A POTENTIAL LOW-LEVEL CONTAMINATION EVENT DURING THE MANUFACTURING OF THIS LOT. EACH BIOFIRE REAGENT LOT IS QUALIFIED PRIOR TO PRODUCT RELEASE; THIS QUALIFICATION INCLUDES A HIGH STATISTICAL-CONFIDENCE SAMPLING TO CONFIRM THAT THE KIT COMPONENTS RELEASED FOR CUSTOMER USE ARE CONFORMING. ALL QC METRICS FOR THE POUCH LOT WERE MET, SUGGESTING CONTAMINATION EXISTS BELOW LOD OR WAS LIMITED TO A SMALL PORTION WITHIN THE LOT. PER THE JI PANEL INSTRUCTIONS FOR USE [RFIT-PRT-0690], FALSE POSITIVE RESULTS CAN BE THE RESULT OF A VARIETY OF SOURCES AND CAUSES; IT IS IMPORTANT THAT RESULTS BE USED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, OR LABORATORY INFORMATION. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 20, 49, AND 50 OF THE BIOFIRE® JOINT INFECTION (JI) PANEL INSTRUCTIONS FOR USE (HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/US/EN/ALL?KEYCODE=ITI0017).

    Description of Event or Problem · 0

    THE CUSTOMER (USA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THE PATIENT WAS NOT IMPACTED. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY THE CAUSE OF THE FALSE POSITIVE S. AUREUS RESULT WAS CONTAMINATION DURING MANUFACTURING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470738 BIOFIRE JOINT INFECTION (JI) PANEL BIOFIRE JOINT INFECTION (JI) PANEL QSN BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0138 0878825 00815381020192

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female