BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE JOINT INFECTION PANEL

    MDR report key: 24760910 · Received April 1, 2026

    Report

    Report Number
    3002773840-2026-00006
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    January 16, 2026
    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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(6) HOSPITAL ((B)(6) SPAIN) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT'S SAMPLE. THE PATIENT'S SYMPTOMS/REASON FOR VISIT WAS REQUESTED AND NOT PROVIDED. ON (B)(6) 2026, AN UNKNOWN SAMPLE WAS TESTED ON THE BIOFIRE JI PANEL. THE JI PANEL REPORTED S. AUREUS AS DETECTED. ON AN UNKNOWN DATE, OTHER UNKNOWN METHODOLOGIES WERE PERFORMED AND DID NOT DETECT S. AUREUS. THE JI PANEL WAS DISCORDANT WITH THE COMPARATOR METHOD. THE CUSTOMER INDICATED THE S. AUREUS RESULT WAS REPORTED TO THE CLINICIAN AND THE PATIENT WAS TAKEN TO THE SURGERY ROOM WITHOUT IT BEING NECESSARY. HOWEVER, NO PATIENT HARM WAS REPORTED. THE ANALYSIS OF THE JI PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED LATE AMPLIFICATION, SUGGESTING THAT THE TARGET NUCLEIC ACID WAS PRESENT AT LOW LEVELS. QUALITY CONTROL (QC) RECORDS FOR KIT/POUCH LOT 0878825/3RXZ25 AND INSTRUMENT (B)(6) WERE REVIEWED. THE POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATION. THE FILMARRAY INSTRUMENT (SERIAL # (B)(6)) WAS WORKING WITHIN DESIGNED SPECIFICATIONS. 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 INSTRUCTION BOOKLET. HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/US/ALL?KEYCODE=ITI0017.

    Description of Event or Problem · 0

    SUMMARY: THE CUSTOMER ((B)(6) SPAIN) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT'S SAMPLE. THE CUSTOMER INDICATED THE S. AUREUS RESULT WAS REPORTED TO THE CLINICIAN, AND THE PATIENT WAS TAKEN TO THE SURGERY ROOM WITHOUT IT BEING NECESSARY. HOWEVER, NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS CONTAMINATION DURING MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193908 BIOFIRE JOINT INFECTION PANEL BIOFIRE JOINT INFECTION PANEL QSN BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0138 0878825 00815381020192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown