BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE JOINT INFECTION PANEL, 30 TESTS - RFIT-ASY-0138

    MDR report key: 25318403 · Received May 28, 2026

    Report

    Report Number
    3002773840-2026-00015
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QSN
    UDI-DI
    00815381020192
    PMA / PMN Number
    DEN200066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PATIENT INFORMATION SUCH AS SIGS/SYMPTOMS, AGE, SEX, AND FINAL DIAGNOSIS WERE REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED. ONE(B)(6) 2026, A PERIPROSTHETIC TISSUE SPECIMEN WAS TESTED WITH ON THE BIOFIRE JOINT INFECTION (JI) PANEL. THE JI PANEL REPORTED S. AUREUS AS DETECTED. ON AN UNKNOWN DATE, AEROBIC AND ANEROBIC CULTURE WERE PERFORMED AND WERE BOTH NEGATIVE. THE JI PANEL WAS DISCORDANT WITH COMPARATOR METHODS. THE CUSTOMER REPORTED THE PATIENT WAS AFFECTED DUE TO LIKELY BEING MISCLASSIFIED. NO PATIENT HARM WAS REPORTED. THE ANALYSIS OF THE JI PANEL RUN FILE 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. CONCLUSION: DURING THE INVESTIGATION IT WAS DETERMINED THAT THE CUSTOMER WAS TESTING AN OFF-LABEL SAMPLE TYPE. THE CUSTOMER REPORTED THEY WERE USING PERIPROSTHETIC TISSUE SAMPLES ON THE JI PANEL WHICH IS CONSIDERED OFF-LABEL USE. THE PERFORMANCE OF THIS TEST HAS ONLY BEEN VALIDATED WITH SYNOVIAL FLUID COLLECTED ACCORDING TO STANDARD TECHNIQUE. THE CUSTOMER REPORTED THESE RESULTS FOLLOWING RECEIPT OF FIELD SAFETY CORRECTIVE ACTION, FA-TWD-000074, WHICH IDENTIFIED AN INCREASED RISK OF FALSE POSITIVE S. AUREUS ON KIT/POUCH LOT 0878825/(B)(6). THUS, A LIKELY CAUSE OF DISCREPANT RESULTS WAS DUE TO CONTAMINATION DURING MANUFACTURING. ALTERNATIVELY, DUE TO THE HIGH SENSITIVITY OF THE BIOFIRE JI PANEL AND THE ABILITY OF THE BIOFIRE JI PANEL TO DETECT ALL ORGANISM TARGETS DIRECTLY FROM THE PATIENT'S SAMPLE RATHER THAN ISOLATED COLONIES FROM CULTURE, DISCREPANCIES WITH STANDARD PHENOTYPIC MICROBIAL IDENTIFICATION AND SUSCEPTIBILITY TECHNIQUES CAN OCCUR AND ARE A PART OF NORMAL SYSTEM PERFORMANCE, ESPECIALLY IN INSTANCES OF LOW-LEVEL ORGANISM. DUE TO THE SENSITIVE NATURE OF THE JI PANEL, THERE IS A RISK OF FALSE POSITIVE RESULTS FROM THE INTRODUCTION OF EXOGENOUS ORGANISM OR NUCLEIC ACID. WHILE THE POUCH LOADING INSTRUCTIONS AND RECOMMENDED CLEANING STEPS ARE SUFFICIENT TO ELIMINATE CONTAMINATION THE MAJORITY OF THE TIME, IT IS POSSIBLE THAT SOME ORGANISM/NUCLEIC ACID COULD BE INTRODUCED DURING ANY PART OF THE TESTING AND POUCH HANDLING PROCESS. CONTAMINATION CAN ALSO BE INTRODUCED VIA THE LABORATORY ENVIRONMENT AND EQUIPMENT SUCH AS PIPETTES, PIPETTE TIPS, ETC., OR PERSONNEL HANDLING THE SAMPLE. CAREFUL ADHERENCE TO THE SAMPLE PROCESSING STEPS DESCRIBED IN THE INSTRUCTIONS FOR USE [RFIT-PRT-0690] AND CONTAMINATION PREVENTION AND DECONTAMINATION TECHNICAL NOTE [FLM1-PRT-0230] IS RECOMMENDED TO AVOID POSSIBLE CONTAMINATION. THE CUSTOMER IS ADVISED TO FOLLOW THE INSTRUCTIONS IN THE FIELD SAFETY CORRECTION ACTION CUSTOMER LETTER AND DESTROY ANY REMAINING UNUSED PRODUCT FROM THE BIOFIRE JI KIT/POUCH LOT 0878825/(B)(6). CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 20, 22, 29-30, 49, AND 50 OF THE BIOFIRE® JOINT INFECTION (JI) PANEL INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    THE CUSTOMER (POLAND) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PERIPROSTHETIC TISSUE SAMPLE. NOTE, THIS SAMPLE TYPE IS CONSIDERED OFF-LABEL USE. THE CUSTOMER REPORTED THE PATIENT WAS AFFECTED DUE TO EXCESSIVE ANTIBIOTIC TREATMENT. THE CUSTOMER DID NOT CONSIDER THE TREATMENT INAPPROPRIATE BUT NOTED THAT IT WAS EXCESSIVE. THE CUSTOMER REPORTED THERE WAS NO DETERIORATION IN HEALTH DUE TO THE TREATMENT AT THIS TIME. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE CUSTOMER WAS TESTING AN OFF-LABEL SAMPLE TYPE. HOWEVER, THE CUSTOMER REPORTED THESE RESULTS FOLLOWING RECEIPT OF FIELD SAFETY CORRECTIVE ACTION, FA-TWD-000074, WHICH IDENTIFIED AN INCREASED RISK OF FALSE POSITIVE S. AUREUS ON KIT/POUCH LOT 0878825/(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164445 BIOFIRE JOINT INFECTION PANEL, 30 TESTS - RFIT-ASY-0138 BIOFIRE JOINT INFECTION PANEL, 30 TESTS - RFIT-ASY-0138 QSN BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0138 0878825 00815381020192

    Patients

    Seq Age Sex Outcome Treatment
    1