BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFIRE ME PANEL

    MDR report key: 23600759 · Received November 19, 2025

    Report

    Report Number
    3002773840-2025-00079
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PLO
    UDI-DI
    00815381020123
    PMA / PMN Number
    K160462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A 46-YEAR-OLD IMMUNOCOMPROMISED FEMALE PATIENT PRESENTED WITH WEAKNESS, TIREDNESS, AND SOME DIZZINESS AT THE TIME OF TESTING. IT WAS NOTED THAT THIS PATIENT HAS ADVANCED AIDS WITH CD4 <20 AND HIV VL AT BASELINE 233,000 COPIES/ML. ON (B)(6) 2025, A CEREBROSPINAL FLUID (CSF) SAMPLE WAS COLLECTED VIA LUMBAR PUNCTURE. INITIAL TESTING WAS PERFORMED THE SAME DAY USING THE ME PANEL, AND A 'NOT DETECTED' RESULT WAS REPORTED FOR ALL ANALYTES. THE PATIENT WAS NOT RECEIVING ANTIFUNGAL TREATMENT PRIOR TO CSF COLLECTION. ON AN UNKNOWN DATE, FUNGAL CULTURE IDENTIFIED CRYPTOCOCCUS NEOFORMANS/GATTII. THE RESULTS REPORTED TO THE PHYSICIAN WERE: NO TARGETS DETECTED BY ME PANEL, AND FUNGAL CULTURE IDENTIFIED CRYPTOCOCCUS NEOFORMANS/GATTII. ON AN UNKNOWN DATE, CRYPTOCOCCAL ANTIGEN RETURNED POSITIVE. THIS RESULT CONFIRMED THE PATIENT¿S CRYPTOCOCCAL INFECTION, AND THE PATIENT WAS STARTED ON ANTIFUNGAL THERAPY. THERE WAS A 13-DAY DELAY IN STARTING ANTIFUNGAL TREATMENT THAT WOULD BE INDICATED FOR CNS CRYPTOCOCCAL INFECTION (I.E. AMPHOTERICIN B), DUE TO THE ME PANEL RESULTS. THE PHYSICIAN STATED THAT THE PATIENT DETERIORATED DUE TO THE DELAY; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED. THE PATIENT'S FINAL DIAGNOSIS WAS CRYPTOCOCCOSIS. THE PATIENT HAS COMPLETED INDUCTION THERAPY FOR CRYPTOCOCCAL MENINGITIS WITH LIPOSOMAL AMPHOTERICIN B AND IS NOW ON FLUCONAZOLE THERAPY. THE ANALYSIS OF THE PROVIDED ME PANEL RUN FILE REVEALED A FLATLINE SIGNATURE UNDER THE CRYPTOCOCCUS ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3P9N25 (KIT LOT# 0362325) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE, AND THE FILMARRAY INSTRUMENT (SERIAL NUMBER# (B)(6) WAS WORKING WITHIN THE DESIGNED SPECIFICATIONS. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE CRYPTOCOCCUS NEOFORMANS/GATTII DISCREPANT RESULT WAS DUE TO SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AND TRADITIONAL TESTING. THE ME PANEL RESULTED IN NEGATIVE RESULTS FOR ALL TARGETS, AND FUNGAL CULTURE IDENTIFIED C. NEOFORMANS/GATTII IN THIS SAMPLE. IT WAS IDENTIFIED THAT THE CUSTOMER PERFORMED ANTIGEN TESTING ON THIS SAMPLE, AND RESULTS WERE POSITIVE. RUN FILE ANALYSIS OBSERVED A FLAT-LINED SIGNATURE FOR THE CRYPTOCOCCUS ASSAY, SUGGESTING A NUCLEIC ACID WAS PRESENT IN THE SAMPLE AT A CONCENTRATION BELOW THE LIMIT OF DETECTION. IT SHOULD BE NOTED THAT, DEPENDING ON THE STAGE OF THE DISEASE, ANTIGEN VERSUS NUCLEIC ACID CONCENTRATIONS MAY VARY, ALLOWING FOR DISCREPANCIES TO OCCUR (THIS MAY BE OBSERVED LATE IN THE DISEASE LIFE CYCLE). DISCREPANCIES MAY BE MORE LIKELY TO OCCUR IN SAMPLES CONTAINING LOW LEVELS OF THE TARGET. THE ME PANEL IS A HIGHLY SENSITIVE, MULTIPLEXED, NUCLEIC ACID-BASED TEST DESIGNED TO DETECT MULTIPLE VIRAL, BACTERIAL, AND YEAST NUCLEIC ACIDS DIRECTLY FROM CEREBROSPINAL FLUID (CSF) SPECIMENS OBTAINED VIA LUMBAR PUNCTURE FROM INDIVIDUALS WITH SIGNS AND/OR SYMPTOMS OF MENINGITIS AND/OR ENCEPHALITIS. THE ME PANEL IS HIGHLY SENSITIVE AND SPECIFIC AND THERE CAN BE DISCREPANCIES BETWEEN IT AND TRADITIONAL IDENTIFICATION METHODS. WHILE UNCOMMON, DISCREPANCIES BETWEEN THE ME PANEL AND TRADITIONAL METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT OBSERVED IN THE FIELD. ACCORDING TO THE ¿CRYPTOCOCCUS DETECTION BY THE BIOFIRE® FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL¿ TECHNICAL NOTE [FLM1-PRT-0278], THE MOST SENSITIVE TEST FOR PRIMARY CRYPTOCOCCAL MENINGITIS (CM) IS THE DETECTION OF CRYPTOCOCCAL ANTIGEN (CRAG) IN CSF OR BLOOD. THERE HAVE BEEN REPORTS OF NEGATIVE RESULTS BY THE ME PANEL IN PATIENTS WITH NEWLY DIAGNOSED CRYPTOCOCCAL MENINGITIS AND POSITIVE CRAG AND/OR CULTURE. THIS CAN HAPPEN EARLY IN INFECTION WHEN THE DISEASE BURDEN IS LOW. PATIENTS WITH A SUSPICION OF CRYPTOCOCCAL MENINGITIS AND A NEGATIVE CRYPTOCOCCAL PCR RESULT, SUCH AS BY THE ME PANEL, SHOULD BE TESTED FOR CRYPTOCOCCAL ANTIGEN (CRAG). FOR ADDITIONAL INFORMATION, INCLUDING CORRELATION WITH CRAG ASSAYS AND FUNGAL CULTURE, PLEASE REFER TO THE ¿CRYPTOCOCCUS DETECTION BY THE BIOFIRE® FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL¿ TECHNICAL NOTE [FLM1-PRT-0278]. THE LIMITATIONS SECTION OF THE ¿BIOFIRE® FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL INSTRUCTION BOOKLET¿ (WWW.ONLINE-IFU.COM/ITI0035) INCLUDES INFORMATION REGARDING FALSE NEGATIVE ME PANEL RESULTS. THERE ARE MULTIPLE POTENTIAL SOURCES OR CAUSES OF FALSE NEGATIVE RESULTS. A NEGATIVE ME PANEL RESULT DOES NOT EXCLUDE THE POSSIBILITY OF CNS INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER MANAGEMENT DECISIONS. THERE IS RISK OF FALSE NEGATIVE RESULTS DUE TO THE PRESENCE OF SEQUENCE VARIANTS OR REARRANGEMENTS IN THE GENE TARGETS OF THE ASSAY, PROCEDURAL ERRORS, INHIBITORS IN SPECIMENS, TECHNICAL ERROR, SAMPLE MIX-UP, OR INFECTION CAUSED BY AN ORGANISM NOT DETECTED BY THE ME PANEL. ANTIMICROBIAL THERAPY MAY AFFECT (REDUCE) ORGANISM LEVELS IN THE SPECIMEN. IT IS IMPORTANT THAT ALL ME PANEL TEST RESULTS BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, OR LABORATORY INFORMATION. NOTE: IT WAS IDENTIFIED DURING THE INVESTIGATION THAT THE PATIENT WAS IMMUNOCOMPROMISED. IT SHOULD BE NOTED THAT THE PERFORMANCE OF THE ME PANEL HAS NOT BEEN SPECIFICALLY EVALUATED FOR CSF SPECIMENS COLLECTED FROM IMMUNOCOMPROMISED INDIVIDUALS. THE CUSTOMER STATED IT IS UNKNOWN IF THE ME PANEL AND FUNGAL CULTURE WERE PERFORMED ON THE SAME CSF SAMPLE TUBE. IT IS IMPORTANT TO NOTE THAT RESULTS FROM DIFFERENT SAMPLE VIALS TESTED MAY NOT BE DIRECTLY COMPARABLE TO EACH OTHER, DUE TO THE VARIABILITY BETWEEN SAMPLES. EVEN IF MULTIPLE TUBES OF CSF WERE COLLECTED DURING THE SAME EVENT, THERE MAY BE VARIABILITY BETWEEN EACH TUBE. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 9 AND 14 OF THE BIOFIRE® FILMARRAY® ME PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0035).

    Description of Event or Problem · 0

    SUMMARY: (B)(6) MEDICAL CENTER (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT¿S CEREBROSPINAL FLUID (CSF) SAMPLE. DUE TO THE FILMARRAY ME PANEL RESULT, THERE WAS A 13-DAY DELAY IN REPORTING RESULTS, AND THE PATIENT DETERIORATED DUE TO THE DELAY. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE C. NEOFORMANS/GATTII DISCREPANT RESULT WAS DUE TO SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AND TRADITIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578121 BIOFIRE ME PANEL BIOFIRE ME PANEL PLO BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0118 0362325 00815381020123

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female