BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILMARRAY® TORCH MODULE

    MDR report key: 22879216 · Received August 22, 2025

    Report

    Report Number
    3002773840-2025-00060
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    NSU
    UDI-DI
    00815381020277
    PMA / PMN Number
    K160068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE FOLLOWING BIOFIRE BCID2 PANEL RUNS WERE FOUND DISCREPANT ON THE FILMARRAY TORCH MODULE (B)(6): · RUN 1 ((B)(6) 2025) - FALSE NEGATIVE ENTERIC 2, K. OXYTOCA, OXA-48-LIKE, AND K. PNEUMONIAE. · RUN 2 ((B)(6) 2025) - FALSE NEGATIVE ACB COMPLEX, E. CLOACAE, ENTERIC 2, OXA-48-LIKE, AND S. LUGDUNENSIS. · RUN 3 ((B)(6) 2025) - FALSE NEGATIVE ENTERIC 1 AND S. MALTOPHILIA. · RUN 4 ((B)(6) 2025) - FALSE NEGATIVE ENTERIC 1 AND K. PNEUMONIAE. · RUN 5 ((B)(6) 2025) - FALSE NEGATIVE ENTERIC 1, K. PNEUMONIAE, AND OXA-48-LIKE. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. CONCLUSION: N/A FOR INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PATIENT DETAILS WERE NOT PROVIDED. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE FOLLOWING BIOFIRE BCID2 PANEL RUNS WERE FOUND DISCREPANT ON THE FILMARRAY TORCH MODULE (B)(6): RUN 1 (B)(6) 2025) - FALSE NEGATIVE ENTERIC 2, K. OXYTOCA, OXA-48-LIKE, AND K. PNEUMONIAE RUN 2 (B)(6) 2025) - FALSE NEGATIVE ACB COMPLEX, E. CLOACAE, ENTERIC 2, OXA-48-LIKE, AND S. LUGDUNENSIS. RUN 3 (B)(6) 2025) - FALSE NEGATIVE ENTERIC 1 AND S. MALTOPHILIA, RUN 4 (B)(6) 2025) - FALSE NEGATIVE ENTERIC 1 AND K. PNEUMONIAE, RUN 5 (B)(6) 2025) - FALSE NEGATIVE ENTERIC 1, K. PNEUMONIAE, AND OXA-48-LIKE. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3NMP25 (KIT LOT# 0228325) AND FILMARRAY INSTRUMENT (SERIAL NUMBER# (B)(6) WERE REVIEWED. THIS POUCH LOT AND INSTRUMENT PASSED QC CRITERIA. THE DISCREPANCY REPORTED BY THE CUSTOMER WAS NOT OBSERVED DURING QC TESTING. IN-HOUSE INVESTIGATION: UPON INCOMING TESTING OF THE FILMARRAY TORCH MODULE, THE SERVICE TECHNICIANS DISCOVERED LABELS STUCK TO THE CLEAR SHEET COVERING WELLS ON THE MASK FIND IMAGE BLOCKING THE CAMERA AND RESULTING IN FALSE NEGATIVE RESULTS. THE REPORTED ERROR WAS REPLICATED. THE WRAP-AROUND BLADDER PROTECTION SHEET IN THE INSTRUMENT WAS REPLACED DUE TO OBSTRUCTION FROM LABEL. ALL OUTGOING TESTING FOR THE INSTRUMENT WAS COMPLETED WITH PASSING RESULTS. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT RESULT WAS A PATIENT LABEL BECOMING DISLODGED WITHIN THE FILMARRAY TORCH MODULE, OBSTRUCTING THE CAMERA. ANALYSIS OF QC AND PATIENT RUN FILES PROVIDED BY THE CUSTOMER REVEALED ASSAY DROPOUTS LOCALIZED TO THE AREA OF THE ARRAY AFFECTED BY THE OBSTRUCTED VIEW. TO PREVENT THIS ISSUE, CUSTOMERS ARE ADVISED TO APPLY PATIENT LABELS THAT FIT PROPERLY WITHIN THE DESIGNATED "SAMPLE ID HERE" AREA. BIOFIRE IS INVESTIGATING A POTENTIAL LABELING UPDATE TO CLARIFY THIS RECOMMENDATION AND REMAINS COMMITTED TO CONTINUOUS PRODUCT IMPROVEMENT. CLINICAL PERFORMANCE CAN BE FOUND IN BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048).

    Description of Event or Problem · 0

    SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. A MALFUNCTION OF THE FILMARRAY TORCH INSTRUMENT (B)(6) IS SUSPECTED. A FINAL REPORT WITH ALL INVESTIGATION DETAILS WILL BE PROVIDED. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    SUMMARY: (B)(6) REPORTED POTENTIAL FALSE NEGATIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL RUNS ON THE FILMARRAY TORCH MODULE (B)(6). NO PATIENT HARM WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DISCREPANT RESULT WAS A PATIENT LABEL BECOMING DISLODGED WITHIN THE FILMARRAY TORCH MODULE, OBSTRUCTING THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558786 FILMARRAY® TORCH MODULE FILMARRAY® TORCH MODULE NSU BIOFIRE DIAGNOSTICS, LLC HTFA-SUB-0103 N/A 00815381020277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown