BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILMARRAY® PNEUMONIA PANEL PLUS

    MDR report key: 21601876 · Received March 13, 2025

    Report

    Report Number
    3002773840-2025-00015
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    December 20, 2024
    Report Date
    April 10, 2025
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QDS
    PMA / PMN Number
    K243222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PLEASE NOTE THE INITIAL REPORT INCLUDED VIM AND DID NOT INCLUDE IMP. THE FINAL REPORT DISCREPANT ANALYTES ARE CORRECT. THE PATIENT WAS A (B)(6) YEAR-OLD, MALE IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SEDATED AND INTUBATED AT THE TIME OF TESTING. THE CUSTOMER REPORTED X-RAY SHOWED PNEUMONIA. ON (B)(6) 2024, THE PATIENT'S SPUTUM SAMPLE WAS TESTED ON THE FILMARRAY PNEUMONIA PANEL PLUS. THE FILMARRAY PNEUMONIA PANEL PLUS REPORTED HAEMOPHILUS INFLUENZAE, KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS AGALACTIAE, CORONAVIRUS, CTX-M, NDM, AND IMP. THE SAME SAMPLE WAS USED FOR ADDITIONAL TESTING. K. PNEUMONIAE, WILD-TYPE ACINETOBACTER SPP., AND S. AGALACTIAE WERE RECOVERED FROM CULTURE. THE CUSTOMER STATED DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, COLISTIN WAS ADMINISTERED, CAUSING KIDNEY DAMAGE. COLISTIN WAS DISCONTINUED AFTER CULTURE DETERMINED THE DETECTED STRAINS WERE WILD TYPE 72 HOURS LATER. THE ANALYSIS OF THE FILMARRAY PNEUMONIA PANEL PLUS RUN FILE SHOWED LATE AMPLIFICATION SIGNATURES FOR H. INFLUENZAE, INDICATING LOW LEVELS OF TARGET NUCLEIC ACIDS IN THE CLINICAL SAMPLES. ADDITIONALLY, THE AMPLIFICATION SIGNATURES OF THE DISCREPANT AMR GENES WERE ALSO LATE, SUGGESTING THE POSSIBILITY THAT THESE SIGNATURES MAY BE ASSOCIATED WITH AN ORGANISM NOT DETECTED BY FILMARRAY PNEUMONIA PANEL PLUS OR BELONGED TO A SMALL POPULATION OF RESISTANT ORGANISMS PRESENT IN A MIXED CULTURE. THESE DETECTIONS COULD ALSO HAVE BEEN INTRODUCED THROUGH CONTAMINATION. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 37BT24 (KIT LOT# 0202124) WERE REVIEWED. THE 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 DESIGNED SPECIFICATIONS. CONCLUSION: THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE FALSE POSITIVE CORONAVIRUS RESULT WAS NON-SPECIFIC AMPLIFICATION OR CROSS-REACTIVITY OF THE CORONAVIRUS ASSAY WITH HIGH CONCENTRATIONS OF HUMAN GENOMIC DNA (HGDNA). INVESTIGATIONS OF FALSE RESULTS REPORTED FROM THE FIELD HAVE IDENTIFIED A RISK FOR FALSE POSITIVE DETECTION OF SEASONAL CORONAVIRUS DUE TO NON-SPECIFIC AMPLIFICATION OR CROSS-REACTIVITY WITH HIGH CONCENTRATIONS OF HUMAN GENOMIC DNA (HGDNA) THAT COULD BE PRESENT IN CLINICAL SPECIMENS. THE CROSS-REACTIVITY ONLY OCCURS IN SAMPLES CONTAINING HIGH LEVELS OF HUMAN GENOMIC DNA. THE FILMARRAY PNEUMONIA PANEL PLUS INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0038) CONTAINS A LIMITATION FOR ERRONEOUS RESULTS DURING TESTING: "FALSE POSITIVES AND FALSE NEGATIVES 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." DETECTION OF ORGANISM TARGETS DOES NOT IMPLY THAT THE CORRESPONDING ORGANISMS ARE INFECTIOUS OR ARE THE CAUSATIVE AGENTS FOR CLINICAL SYMPTOMS. DETECTION OF TARGET NUCLEIC ACID IS DEPENDENT UPON PROPER HANDLING, STORAGE, AND PREPARATION OF THE SAMPLE. FAILURE TO OBSERVE PROPER PROCEDURES IN ANY ONE OF THESE STEPS CAN LEAD TO INCORRECT RESULTS. THE MOST LIKELY CAUSE OF THE OTHER FALSE POSITIVE RESULTS WAS 1) CONTAMINATION AND/OR 2) COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN FILMARRAY PNEUMONIA PANEL PLUS AND PHENOTYPIC METHODS. 1) DUE TO THE SENSITIVE NATURE OF THE FILMARRAY PNEUMONIA PANEL PLUS, THERE IS A RISK OF FALSE POSITIVE RESULTS FROM THE INTRODUCTION OF EXOGENOUS ORGANISMS OR NUCLEIC ACIDS. WHILE THE POUCH LOADING INSTRUCTIONS AND RECOMMENDED CLEANING STEPS ARE SUFFICIENT TO ELIMINATE CONTAMINATION THE MAJORITY OF THE TIME, IT IS POSSIBLE THAT SOME ORGANISMS/NUCLEIC ACIDS 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. IMPORTANTLY, IT WAS NOTED THAT NO DECONTAMINATION PROCEDURE WAS BEING PERFORMED AT THE CUSTOMER SITE. TO MINIMIZE THE RISK OF CONTAMINATION AND FALSE POSITIVE RESULTS, BIOFIRE RECOMMENDS PERFORMING DECONTAMINATION BETWEEN SPECIMENS USING AN APPROPRIATE DISINFECTANT, SUCH AS 10% BLEACH, FOLLOWED BY RINSING WITH WATER. BIOFIRE ALSO RECOMMENDS LOADING POUCHES INSIDE A BIOSAFETY CABINET OR OTHER CONTAINMENT SYSTEM TO REDUCE THE LIKELIHOOD OF CONTAMINATION. IF FALSE-POSITIVE RESULTS OCCUR AND CONTAMINATION IS SUSPECTED, BIOFIRE RECOMMENDS PERFORMING ENVIRONMENTAL TESTING OR SWABS OF THE AREA WHERE FILMARRAY PNEUMONIA PANEL PLUS TESTING IS CONDUCTED TO IDENTIFY POTENTIAL SOURCES OF CONTAMINATION. IMPLEMENTING THESE BEST PRACTICES CAN HELP ENSURE THE ACCURACY OF RESULTS AND REDUCE THE RISK OF CONTAMINATION IN FUTURE TESTING. FALSE POSITIVE RESULTS CAN ALSO BE CAUSED BY CONTAMINATION OF SPECIMENS OR THE TEST WITH ORGANISMS SHED BY OTHERWISE HEALTHY INDIVIDUALS. H. INFLUENZAE CAN BE SHED FROM THE RESPIRATORY TRACT OF HEALTHY INDIVIDUALS. TO MINIMIZE THE RISK OF FALSE POSITIVE RESULTS DUE TO CONTAMINATION, CAUTION SHOULD BE EXERCISED DURING SPECIMEN COLLECTION AND TESTING. PARTICULAR ATTENTION SHOULD BE GIVEN TO THE "LABORATORY PRECAUTIONS" OF THE FILMARRAY PNEUMONIA PANEL PLUS IFU, AS WELL AS THE "CONTAMINATION PREVENTION AND DECONTAMINATION" TECHNICAL NOTE [FLM1-PRT-0230], TO AVOID POSSIBLE CONTAMINATION. SAMPLES SHOULD BE PROCESSED IN A CLEAN BIOSAFETY CABINET IF AVAILABLE OR ACCORDING TO LOCAL LABORATORY GUIDELINES. IF A BIOSAFETY CABINET IS NOT USED, A DEAD AIR BOX (E.G., AIRCLEAN PCR WORKSTATION), A SPLASH SHIELD (E.G., BEL-ART SCIENCEWARE SPLASH SHIELDS), OR A FACE SHIELD CAN BE USED WHEN PREPARING SAMPLES INSTEAD. 2) THE FALSE POSITIVE H. INFLUENZAE RESULT MAY BE DUE TO THE PRESENCE OF A POLYMICROBIAL CULTURE. RUN FILE ANALYSIS SHOWED LATE AMPLIFICATION SIGNATURE, INDICATING LOW LEVELS OF TARGET NUCLEIC ACID IN THE SAMPLE COMPARED TO OTHER ANALYTES. IT IS POSSIBLE THAT H. INFLUENZAE WAS PRESENT IN THE SAMPLES BUT DID NOT GROW TO A DETECTABLE LEVEL USING TRADITIONAL CULTURE METHODS. THE RUN FILE ANALYSIS ALSO DETECTED AMR GENE TARGETS WITH LATE SIGNATURES, SUGGESTING THAT THESE ANTIMICROBIAL RESISTANCE NUCLEIC ACID SEQUENCES WERE PRESENT AT LOW CONCENTRATIONS. NO RESISTANT ORGANISMS WERE IDENTIFIED, WHICH MAY BE ATTRIBUTED TO SENSITIVITY AND SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS MOLECULAR DETECTION METHOD AND STANDARD PHENOTYPIC CULTURE METHODS. AS OUTLINED IN THE FILMARRAY PNEUMONIA PANEL PLUS IFU, ANTIMICROBIAL RESISTANCE CAN OCCUR VIA MULTIPLE MECHANISMS. A NOT DETECTED RESULT FOR A GENETIC MARKER OF ANTIMICROBIAL RESISTANCE DOES NOT INDICATE SUSCEPTIBILITY TO THE ASSOCIATED ANTIMICROBIAL DRUGS OR DRUG CLASSES. CONVERSELY, A DETECTED RESULT FOR A GENETIC MARKER OF ANTIMICROBIAL RESISTANCE CANNOT BE DEFINITIVELY LINKED TO THE MICROORGANISMS DETECTED. CULTURE IS REQUIRED TO OBTAIN ISOLATES FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING, AND FILMARRAY PNEUMONIA PANEL PLUS RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH CULTURE RESULTS TO DETERMINE SUSCEPTIBILITY OR RESISTANCE. DUE TO THE HIGH SENSITIVITY AND SPECIFICITY OF THE FILMARRAY PNEUMONIA PANEL PLUS AND ITS ABILITY TO DETECT ORGANISMS DIRECTLY FROM THE PATIENT'S SAMPLE RATHER THAN FROM ISOLATED CULTURE COLONIES, DISCREPANCIES WITH STANDARD IDENTIFICATION TECHNIQUES CAN OCCUR AND ARE PART OF NORMAL SYSTEM PERFORMANCE. FALSE POSITIVES AND FALSE NEGATIVES 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE HAEMOPHILUS INFLUENZAE, CORONAVIRUS, CTX-M, NDM, AND VIM RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. 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: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    SUMMARY: PLEASE NOTE THE INITIAL REPORT INCLUDED VIM AND DID NOT INCLUDE IMP. THE FINAL REPORT DISCREPANT ANALYTES ARE CORRECT. FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE HAEMOPHILUS INFLUENZAE, CORONAVIRUS, CTX-M, NDM, AND IMP RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE FALSE POSITIVE CORONAVIRUS RESULT WAS NON-SPECIFIC AMPLIFICATION OR CROSS-REACTIVITY OF THE CORONAVIRUS ASSAY WITH HIGH CONCENTRATIONS OF HUMAN GENOMIC DNA (HGDNA). THE MOST LIKELY CAUSES OF THE OTHER FALSE POSITIVE RESULTS WERE 1) CONTAMINATION AND/OR 2) COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS AND PHENOTYPIC METHODS.

    Description of Event or Problem · 0

    SUMMARY: FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE HAEMOPHILUS INFLUENZAE, CORONAVIRUS, CTX-M, NDM, AND VIM RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031679 FILMARRAY® PNEUMONIA PANEL PLUS FILMARRAY® PNEUMONIA PANEL PLUS QDS BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0143 0202124

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Other