BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOFIRE BCID2 PANEL

    MDR report key: 24946174 · Received April 21, 2026

    Report

    Report Number
    3002773840-2026-00008
    Event Type
    Death
    Date Received
    April 21, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K243759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A BLOOD CULTURE SAMPLE COLLECTED ON (B)(6) 2026 FROM A 71-YEAR-OLD FEMALE PATIENT WITH CLINICAL SIGNS/SYMPTOMS, AT THE TIME OF TESTING, OF FEVER, INCREASED TACHYCARDIA, AND HYPOTENSION. ON (B)(6) AT 0452, THE POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE® BCID2 PANEL. THE BIOFIRE® BCID2 PANEL REPORTED STENOTROPHOMONAS MALTOPHILIA AS NOT DETECTED; REPORTED ENTEROCOCCUS FAECIUM AND VANA/B AS DETECTED. ON (B)(6) AT 0308, GRAM STAIN OBSERVED GRAM-POSITIVE COCCI IN CHAINS. ON (B)(6), CULTURE WAS PERFORMED AND GREW ENTEROCOCCUS FAECIUM. THE CUSTOMER STATED THAT GRAM-NEGATIVE RODS WERE NOT REPORTED UNTIL GROWTH ON PLATES ON (B)(6) AT 2234. GROWTH OF STENOTROPHOMONAS MALTOPHILIA WAS REPORTED ON (B)(6) AT 0408. SUSCEPTIBILITY TESTING OF THE STENOTROPHOMONAS MALTOPHILIA ISOLATE OBSERVED SUSCEPTIBILITY TO MINOCYCLINE, CEFIDEROCOL, AND TRIMETHOPRIM¿SULFAMETHOXAZOLE. THE SAME SAMPLE WAS USED FOR ALL TESTING. THE BIOFIRE® BCID2 PANEL RESULTS WERE CONCORDANT WITH THE INITIAL GRAM STAIN RESULTS BUT DISCORDANT WITH LATER GRAM STAIN RESULTS AND CULTURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS POSSIBLY IMPACTED BY THE BIOFIRE RESULTS. THE MISSED BIOFIRE® BCID2 PANEL DETECTION RESULTED IN A 24-HOUR DELAY IN STARTING PATHOGEN-DIRECTED EMPIRIC THERAPY. DURING THIS TIME, THE PATIENT CLINICALLY DECOMPENSATED AND WAS TRANSFERRED TO THE ICU. THE PATIENT WAS NOTED TO HAVE NEW FEVERS THAT TRIGGERED WORSENING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (HEART RATES INTO THE 150S AND HIGHER). MEDICATIONS REQUIRED TO CONTROL HER HEART RATE RESULTED IN HYPOTENSION, AND SHE WAS TRANSFERRED TO THE ICU FOR CLOSER MONITORING AND MANAGEMENT. SHE REMAINED IN CRITICAL CONDITION OVER THE FOLLOWING DAYS, INCLUDING A PERSISTENT REQUIREMENT FOR VASOPRESSORS TO MAINTAIN HER BLOOD PRESSURE. ON (B)(6), THE PATIENT WAS TRANSITIONED TO COMFORT-FOCUSED CARE AND PASSED THE SAME DAY. ADDITIONAL PATIENT HISTORY: THE PATIENT WAS AN ELDERLY FEMALE WITH WIDELY METASTATIC SMALL-CELL LUNG CANCER THAT INVOLVED OBSTRUCTION OF HER BILIARY TREE. THE PATIENT WAS ADMITTED ON (B)(6) WITH CONCERN FOR RECURRENT OBSTRUCTION AND CHOLANGITIS. THE PATIENT HAD AN ERCP PERFORMED ON (B)(6), WHERE PUS WAS SWEPT FROM THE DUCT, AND A STENT WAS PLACED. THE PATIENT CONTINUED TO HAVE INCREASING LIVER ENZYMES, AND THERE WERE CONCERNS FOR ONGOING BILIARY OBSTRUCTION. A 2ND ERCP WAS PERFORMED ON (B)(6) WITH FURTHER CLOT SWEEPS AND A STENT EXCHANGE. AT THIS TIME, PUS WAS SEEN FLOWING FROM THE DUCTS, CONSISTENT WITH CHOLANGITIS. THE PATIENT'S LIVER ENZYMES IMPROVED FOLLOWING THE 2ND ERCP PROCEDURE AND THERE WERE NO FURTHER CONCERNS FOR REPEAT BLOCKAGE DOCUMENTED BY THE PHYSICIANS. BLOOD CULTURE HISTORY: (B)(6): 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR ENTEROCOCCUS FAECIUM (AMP S). (B)(6): A BLOOD CULTURE BOTTLE WAS POSITIVE FOR ENTEROCOCCUS FAECIUM. (B)(6): 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR ENTEROCOCCUS FAECIUM (VRE). (B)(6): 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR VRE. (B)(6): 2 BLOOD CULTURE BOTTLES HAD NO GROWTH. (B)(6): A BLOOD CULTURE BOTTLE WAS POSITIVE FOR ENTEROCOCCUS FAECIUM AND VANA/B BY BIOFIRE® BCID2 PANEL AND STENOTROPHOMONAS MALTOPHILIA IN CULTURE (SEE DETAILS ABOVE). TREATMENT HISTORY: (B)(6): PIPERACILLIN-TAZOBACTAM WAS STARTED DUE TO CONCERN FOR CHOLANGITIS ON ADMISSION (B)(6): AMPICILLIN WAS STARTED, TARGETING ENTEROCOCCUS FAECIUM FROM BLOOD CX (B)(6): UNASYN WAS STARTED; BROADENED FOR MORE GENERAL GI COVERAGE, INCLUDING ENTEROCOCCUS FAECALIS (B)(6): DAPTOMYCIN WAS CHANGED TO COVER ENTEROCOCCUS FAECALIS AND VRE (B)(6): CEFEPIME WAS STARTED AFTER THE BLOOD CULTURE OF MARCH 15 RESULTS WERE UPDATED FOR GNR GROWING ON PLATES; THE PATIENT WAS TRANSFERRED TO THE ICU AROUND THIS TIME (B)(6): METRONIDAZOLE WAS STARTED WITH THE ICU TRANSFER (B)(6): CASPOFUNGIN WAS STARTED WITH THE ICU TRANSFER AND A BETA-D-GLUCAN THAT CAME BACK POSITIVE (B)(6): MINOCYCLINE WAS STARTED AFTER STENOTROPHOMONAS MALTOPHILIA WAS REPORTED (B)(6): BACTRIM WAS STARTED AFTER STENOTROPHOMONAS MALTOPHILIA WAS REPORTED (B)(6): CEFIDERICOL REPLACED THE BACTRIM DUE TO WORSENING KIDNEY FUNCTION ANALYSIS OF THE RUN FILE AND LOT: THE ANALYSIS OF THE BIOFIRE® BCID2 PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED LATE SIGNATURES, SUGGESTING THAT THE TARGET NUCLEIC ACID WAS PRESENT AT LOW LEVELS IN THE SAMPLE. QC RECORDS FOR LOT 2216225 WERE REVIEWED. ALL QC METRICS FOR THE POUCH LOT WERE MET AND PASSED QC. THE DISCREPANCIES REPORTED BY THE CUSTOMER WERE NOT OBSERVED DURING THE QC TESTING OF THIS LOT. THE BIOFIRE REAGENT LOTS ARE PERFORMING WITHIN SPECIFICATION IN THE FIELD. BIOFIRE'S MEDICAL AFFAIRS TEAM PERFORMED AN ANALYSIS FOR THIS CASE: IN THIS CASE, THE BIOFIRE® BCID2 PANEL RESULT WAS CONCORDANT WITH THE GRAM STAIN FINDINGS AT THE TIME OF REPORTING, SHOWING ONLY GRAM-POSITIVE COCCI. HOWEVER, GRAM-NEGATIVE RODS WERE DETECTED LATER, SUGGESTING DELAYED GROWTH OR LOWER INITIAL BACTERIAL BURDEN. STENOTROPHOMONAS MALTOPHILIA WAS IDENTIFIED APPROXIMATELY 24 HOURS AFTER THE BIOFIRE® BCID2 PANEL RESULT, RESULTING IN AN ESTIMATED 24-HOUR DELAY IN INITIATION OF TARGETED THERAPY. BASED ON THE PROVIDED INFORMATION, IT APPEARS THAT THE SECOND ERCP ALLOWED TO CONTROL THE SOURCE OF THE INFECTION. THE PATIENT WAS FINALLY PRESCRIBED WITH AN APPROPRIATE THERAPY ACTIVE AGAINST S. MALTOPHILIA; HOWEVER, DESPITE THIS, SHE WAS TRANSFERRED TO COMFORT CARE, WHERE SHE DIED, SUGGESTING AN INCURABLE CONDITION. THIS INFORMATION ADDS WEIGHT TO THE POSSIBILITY THAT THE 24-HOUR DELAY IN APPROPRIATE THERAPY FOR S. MALTOPHILIA MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH. IN SUMMARY, ALTHOUGH, THE IDENTIFICATION OF POLYMICROBIAL INFECTIONS IS A KNOWN LIMITATION OF MULTIPLEX PCR TEST, HIGHLIGHTED IN BIOFIRE® BCID2 PANEL IFU, BASED ON THE PROVIDED DATA, A POTENTIAL CONTRIBUTION OF THE STENOTROPHOMONAS MALTOPHILIA NON-DETECTION BY BIOFIRE® BCID2 PANEL TO THE DELAY IN APPROPRIATE THERAPY AND PATIENTS¿ DEATH CANNOT BE RULED OUT. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT STENOTROPHOMONAS MALTOPHILIA RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN BIOFIRE® BCID2 PANEL AND COMPARATOR CULTURE AND PHENOTYPIC LABORATORY IDENTIFICATION METHODS, WITHIN A POLYMICROBIAL SAMPLE. THE RUN FILE PROVIDED SHOWED ROBUST SIGNATURES FOR E. FAECIUM AND VANA/B. GRAM STAIN RESULTS SHOWED GRAM-POSITIVE COCCI IN CHAINS. CULTURE GROWTH SHOWED E. FAECIUM (VANCOMYCIN RESISTANT) AND S. MALTOPHILIA, IDENTIFIED BY MALDI-TOF. HOWEVER, S. MALTOPHILIA WAS NOT DETECTED BY THE BIOFIRE® BCID2 PANEL DESPITE SOME LATE SIGNATURES BEING PRESENT AND GRAM-NEGATIVE BACILLI WERE NOT SEEN IN GRAM STAIN. BASED ON THE RESULTS OBSERVED, IT IS LIKELY THAT THE BLOOD CULTURE BOTTLE WAS DRIVEN TO POSITIVITY BY THE METABOLIC GROWTH OF THE PRIMARY ORGANISM, E. FAECIUM, WHILE S. MALTOPHILIA WAS PRESENT WITHIN THE SAMPLE BUT OUTCOMPETED OR UNABLE TO GROW TO A LEVEL DETECTABLE BY THE BIOFIRE® BCID2 PANEL. THE BIOFIRE® BCID2 PANEL IS A HIGHLY SENSITIVE, MULTIPLEXED, NUCLEIC-ACID BASED TEST DESIGNED TO DETECT MULTIPLE BACTERIAL, ANTIMICROBIAL RESISTANCE, AND YEAST NUCLEIC ACIDS. THE POLYMICROBIAL NATURE OF THE SPECIMEN CAN POSE UNIQUE CHALLENGES FOR BOTH METHODS, POTENTIALLY SKEWING THE REPRESENTATION OF THE MICROBIAL POPULATION. AS DESCRIBED IN THE LIMITATIONS SECTION OF THE BIOFIRE® BCID2 PANEL PACKAGE INSERT, IN MIXED CULTURES THE BIOFIRE® BCID2 PANEL MAY NOT IDENTIFY ALL TARGETED ORGANISMS IN THE SPECIMEN, DEPENDING UPON THE CONCENTRATION OF EACH TARGET PRESENT. IN PARTICULAR, FALSE NEGATIVE RESULTS FOR STENOTROPHOMONAS SPP. MAY OCCUR IF ANOTHER ORGANISM IS PRESENT IN THE BLOOD CULTURE. NOTE: IT WAS MENTIONED THAT THE PATIENT HAD BEEN TREATED WITH ANTIBIOTICS PRIOR TO USE OF THE BIOFIRE® BCID2 PANEL. THE PERFORMANCE OF THE BIOFIRE® BCID2 PANEL HAS NOT BEEN ESTABLISHED FOR MONITORING TREATMENT OF INFECTION AND THE EFFECT OF ANTIBIOTIC TREATMENT ON TEST PERFORMANCE HAS NOT BEEN STUDIED. FALSE NEGATIVE RESULTS CAN BE THE RESULT OF A VARIETY OF SOURCES AND CAUSES. ALTHOUGH RARE, DISCREPANCIES BETWEEN TESTING METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT, AND NEGATIVE RESULTS SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT OR OTHER MANAGEMENT DECISIONS. ALL IDENTIFICATION RESULTS PROVIDED BY THE BIOFIRE® BCID2 PANEL ARE INTENDED TO BE INTERPRETED IN CONJUNCTION WITH GRAM STAIN RESULTS. RESULTS FROM THIS TEST MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. CLINICAL PERFORMANCE CAN BE FOUND IN TABLE 37. BIOFIRE® BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, STENOTROPHOMONAS MALTOPHILIA OF THE BIOFIRE® BCID2 PANEL INSTRUCTIONS FOR USE [HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/ALL?KEYCODE=ITI0048].

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ARUP, INC (SALT LAKE CITY, UT) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A SAMPLE FROM A 71-YEAR-OLD FEMALE PATIENT BLOOD CULTURE SAMPLE COLLECTED ON (B)(6) 2026. THE PATIENT WAS AN ELDERLY FEMALE WITH WIDELY METASTATIC SMALL-CELL LUNG CANCER THAT INVOLVED OBSTRUCTION OF HER BILIARY TREE. THE PATIENT WAS ADMITTED ON (B)(6) 2026 WITH CONCERN FOR RECURRENT OBSTRUCTION AND CHOLANGITIS. THE PATIENT HAD AN ERCP PERFORMED ON (B)(6) 2026. THE PATIENT HAD CLINICAL SIGNS/SYMPTOMS AT THE TIME OF TESTING OF FEVER, INCREASED TACHYCARDIA, AND HYPOTENSION. ON (B)(6) 2026 AT 0452, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE® BCID2 PANEL. THE BIOFIRE® BCID2 PANEL REPORTED STENOTROPHOMONAS MALTOPHILIA AS NOT DETECTED; REPORTED ENTEROCOCCUS FAECIUM AND VANA/B AS DETECTED. ON (B)(6) 2026 AT 0308, GRAM STAIN OBSERVED GRAM-POSITIVE COCCI IN CHAINS. ON (B)(6) 2026, CULTURE WAS PERFORMED AND GREW ENTEROCOCCUS FAECIUM. THE CUSTOMER STATED THAT GRAM-NEGATIVE RODS WERE NOT REPORTED UNTIL GROWTH ON PLATES ON (B)(6) 2026 AT 2234. GROWTH OF STENOTROPHOMONAS MALTOPHILIA WAS REPORTED ON (B)(6) 2026 AT 0408. THE SAME SAMPLE WAS USED FOR ALL TESTING. THE BCID2 PANEL WAS CONCORDANT WITH THE INITIAL GRAM STAIN RESULTS BUT DISCORDANT WITH LATER GRAM STAIN RESULTS AND CULTURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS POSSIBLY IMPACTED BY THE BIOFIRE RESULTS. THE MISSED BIOFIRE® BCID2 PANEL DETECTION RESULTED IN A 24-HOUR DELAY IN STARTING PATHOGEN-DIRECTED EMPIRIC THERAPY. DURING THIS TIME, THE PATIENT CLINICALLY DECOMPENSATED AND WAS TRANSFERRED TO THE ICU. THE PATIENT WAS NOTED TO HAVE NEW FEVERS THAT TRIGGERED WORSENING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (HEART RATES INTO THE 150S AND HIGHER). MEDICATIONS REQUIRED TO CONTROL HER HEART RATE RESULTED IN HYPOTENSION, AND SHE WAS TRANSFERRED TO THE ICU FOR CLOSER MONITORING AND MANAGEMENT. SHE REMAINED IN CRITICAL CONDITION OVER THE FOLLOWING DAYS, INCLUDING A PERSISTENT REQUIREMENT FOR VASOPRESSORS TO MAINTAIN HER BLOOD PRESSURE. ON (B)(6) 2026, THE PATIENT WAS TRANSITIONED TO COMFORT-FOCUSED CARE AND PASSED THE SAME DAY. BLOOD CULTURE HISTORY: (B)(6) 2026: 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR ENTEROCOCCUS FAECIUM (AMP S). (B)(6) 2026: A BLOOD CULTURE BOTTLE WAS POSITIVE FOR ENTEROCOCCUS FAECIUM. (B)(6) 2026: 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR ENTEROCOCCUS FAECIUM (VRE). (B)(6) 2026: 2 BLOOD CULTURE BOTTLES WERE POSITIVE FOR VRE. (B)(6) 2026: 2 BLOOD CULTURE BOTTLES HAD NO GROWTH. (B)(6) 2026: A BLOOD CULTURE BOTTLE WAS POSITIVE FOR ENTEROCOCCUS FAECIUM AND VANA/B BY BIOFIRE® BCID2 PANEL AND STENOTROPHOMONAS MALTOPHILIA IN CULTURE (SEE DETAILS ABOVE). TREATMENT HISTORY: MARCH 5-7: PIPERACILLIN-TAZOBACTAM WAS STARTED DUE TO CONCERN FOR CHOLANGITIS ON ADMISSION. (B)(6) 2026: AMPICILLIN WAS STARTED, TARGETING ENTEROCOCCUS FAECIUM FROM BLOOD CX. (B)(6) 2026: UNASYN WAS STARTED; BROADENED FOR MORE GENERAL GI COVERAGE, INCLUDING ENTEROCOCCUS FAECALIS. (B)(6) 2026: DAPTOMYCIN WAS CHANGED TO COVER ENTEROCOCCUS FAECALIS AND VRE. (B)(6) 2026: CEFEPIME WAS STARTED AFTER THE BLOOD CULTURE OF MARCH 15 RESULTS WERE UPDATED FOR GNR GROWING ON PLATES; THE PATIENT WAS TRANSFERRED TO THE ICU AROUND THIS TIME. (B)(6) 2026: METRONIDAZOLE WAS STARTED WITH THE ICU TRANSFER. (B)(6) 2026: CASPOFUNGIN WAS STARTED WITH THE ICU TRANSFER AND A BETA-D-GLUCAN THAT CAME BACK POSITIVE. (B)(6) 2026: MINOCYCLINE WAS STARTED AFTER STENOTROPHOMONAS MALTOPHILIA WAS REPORTED. (B)(6) 2026: BACTRIM WAS STARTED AFTER STENOTROPHOMONAS MALTOPHILIA WAS REPORTED. (B)(6) 2026: CEFIDERICOL REPLACED THE BACTRIM DUE TO WORSENING KIDNEY FUNCTION. BIOFIRE'S MEDICAL AFFAIRS TEAM PERFORMED AN ANALYSIS FOR THIS CASE: IN THIS CASE, THE BIOFIRE® BCID2 PANEL RESULT WAS CONCORDANT WITH THE GRAM STAIN FINDINGS AT THE TIME OF REPORTING, SHOWING ONLY GRAM-POSITIVE COCCI. HOWEVER, GRAM-NEGATIVE RODS WERE DETECTED LATER, SUGGESTING DELAYED GROWTH OR LOWER INITIAL BACTERIAL BURDEN. STENOTROPHOMONAS MALTOPHILIA WAS IDENTIFIED APPROXIMATELY 24 HOURS AFTER THE BIOFIRE® BCID2 PANEL RESULT, RESULTING IN AN ESTIMATED 24-HOUR DELAY IN INITIATION OF TARGETED THERAPY. BASED ON THE PROVIDED INFORMATION, THE DIAGNOSTIC ERCP WAS DONE; HOWEVER, CONSIDERING THE PATIENT¿S SEVERITY, IT WAS VERY UNLIKELY THAT BILIARY TRACT OBSTRUCTION WAS ADEQUATELY ADDRESSED, AS IT WOULD REQUIRE AN INVASIVE INTERVENTION. CHOLANGITIS SECONDARY TO MALIGNANT BILIARY OBSTRUCTION IS FUNDAMENTALLY A SOURCE CONTROL-DEPENDENT INFECTION. IF MALIGNANT BILIARY OBSTRUCTION WAS NOT EFFECTIVELY RELIEVED, RECOVERY FROM SEVERE CHOLANGITIS AND SEPTIC SHOCK WOULD BE HIGHLY UNLIKELY, IRRESPECTIVE OF ANTIMICROBIAL THERAPY. THE VRE BACTEREMIA HAS NOT BEEN CLEARED IN 5 DAYS SINCE INITIATION OF ACTIVE THERAPY (DAPTOMYCIN), WHICH MIGHT BE SUGGESTIVE OF A SOURCE CONTROL ISSUE. THE PATIENT WAS FINALLY PRESCRIBED APPROPRIATE THERAPY; HOWEVER, DESPITE THIS, SHE WAS TRANSFERRED TO THE COMFORT CARE, WHERE SHE DIED, SUGGESTING AN INCURABLE CONDITION. IN SUMMARY, BASED ON THE PROVIDED DATA, A POTENTIAL CONTRIBUTION OF STENOTROPHOMONAS MALTOPHILIA NON-DETECTION BY BIOFIRE® BCID2 PANEL TO THE DELAY IN APPROPRIATE THERAPY CANNOT BE RULED OUT. HOWEVER, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THIS DELAY DIRECTLY CONTRIBUTED TO THE PATIENT¿S DEATH, CONSIDERING THE PRESENCE OF ADVANCED METASTATIC MALIGNANCY, ISSUES WITH SOURCE CONTROL, AND THE ONGOING TREATMENT. THEREFORE, NO CAUSAL LINK BETWEEN BIOFIRE® BCID2 PANEL RESULT AND THE PATIENT¿S DEATH CAN BE ESTABLISHED. CONCLUSION: 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 SUPPLEMENTAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    SUMMARY: THE CUSTOMER ((B)(6), UT) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS POSSIBLY IMPACTED BY THE BIOFIRE RESULTS. THE MISSED BIOFIRE® BCID2 PANEL DETECTION RESULTED IN A 24-HOUR DELAY IN STARTING PATHOGEN-DIRECTED EMPIRIC THERAPY. DURING THIS TIME, THE PATIENT CLINICALLY DECOMPENSATED AND WAS TRANSFERRED TO THE ICU. THE PATIENT EVENTUALLY EXPIRED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULTS WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN BIOFIRE® BCID2 PANEL AND COMPARATOR CULTURE AND PHENOTYPIC LABORATORY IDENTIFICATION METHODS, WITHIN A POLYMICROBIAL SAMPLE.

    Description of Event or Problem · 0

    SUMMARY: THE CUSTOMER ((B)(6)) REPORTED A POTENTIAL FALSE NEGATIVE STENOTROPHOMONAS MALTOPHILIA RESULT ON THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS POSSIBLY IMPACTED BY THE BIOFIRE RESULTS. THE MISSED BCID2 PANEL DETECTION RESULTED IN A 24-HOUR DELAY IN STARTING PATHOGEN-DIRECTED EMPIRIC THERAPY. DURING THIS TIME, THE PATIENT CLINICALLY DECOMPENSATED AND WAS TRANSFERRED TO THE ICU. THE PATIENT EVENTUALLY EXPIRED. 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
    411442 BIOFIRE BCID2 PANEL BIOFIRE BCID2 PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 2216225 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1