BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

Report

Report Number: 3002773840-2025-00075
Event Type: Death
Date Received: September 30, 2025
Date of Event: August 30, 2025
Report Date: October 30, 2025
Manufacturer: BIOFIRE DIAGNOSTICS, LLC
Product Code: PEN
UDI-DI: 00815381020338
PMA / PMN Number: K243759
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION: ON (B)(6) 2025, THE PATIENT'S BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED KLEBSIELLA PNEUMONIAE AS DETECTED (E. FAECALIS WAS NOT DETECTED). THE PATIENT DIED OF SEPSIS ON (B)(6) 2025. BIOFIRE MEDICAL AFFAIRS TEAM IS CURRENTLY ASSESSING THIS CASE. BIOFIRE HAS REQUESTED FURTHER INFORMATION 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: THE PATIENT WAS A 1-YEAR-OLD MALE WHO HAD BEEN HOSPITALIZED SINCE BIRTH. THE PATIENT HAD SHORT BOWEL SYNDROME. A STOMA AND CENTRAL VENOUS (CV) CATHETER WERE PLACED. THE CUSTOMER STATED THAT THE PATIENT HAD BEEN REPEATEDLY HOSPITALIZED DUE TO SEPSIS. THE PATIENT WAS ADMINISTERED VANCOMYCIN AND CEFEPIME FROM (B)(6) 2025, TO (B)(6) 2025, DUE TO A SUSPECTED CATHETER INFECTION. AFTER DISCONTINUATION OF VANCOMYCIN AND CEFEPIME, THE PATIENT WAS RECEIVING TOTAL PARENTERAL NUTRITION DUE TO SHORT BOWEL SYNDROME, HIGH CALORIE INFUSIONS, AND LIPID EMULSIONS. VANCOMYCIN WAS INITIATED AGAIN ON (B)(6) 2025. ON (B)(6) 2025, A PERIPHERAL BLOOD SAMPLE AND A REVERSE BLOOD SAMPLE FROM CV CATHETER WERE COLLECTED AND INOCULATED INTO BLOOD CULTURE MEDIA. ON (B)(6) 2025, 1-2 HOURS AFTER SIGNALING POSITIVE, BOTH BLOOD CULTURE SAMPLES WERE TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED KLEBSIELLA PNEUMONIAE AS DETECTED (E. FAECALIS WAS NOT DETECTED) FOR BOTH BLOOD CULTURE SAMPLES. ON (B)(6) 2025, GRAM-NEGATIVE RODS WERE OBSERVED ON GRAM STAIN. ON AN UNKNOWN DATE, MICROSCAN WALKAWAY DETECTED K. PNEUMONIAE AND E. FAECALIS. ADDITIONALLY, E. FAECALIS AND K. AEROGENES WERE DETECTED VIA WALKAWAY FROM A DIFFERENT BLOOD CULTURE BOTTLE COLLECTED AGAIN FROM THE CV ON (B)(6) 2025. THE CUSTOMER STATED THAT SINCE THE BIOFIRE BCID2 PANEL WAS ONLY POSITIVE FOR K. PNEUMONIAE, VANCOMYCIN WAS DISCONTINUED, AND TREATMENT WAS CHANGED TO CEFOTAXIME ON (B)(6) 2025. THE PATIENT DIED OF SEPSIS ON (B)(6) 2025, 26 HOURS AFTER VANCOMYCIN HAD BEEN DISCONTINUED. THE CUSTOMER REPORTED THE AUTOPSY DID NOT REVEAL ANY ISSUES SUCH AS THROMBOSIS THAT COULD BE LINKED TO THE CAUSE OF DEATH, AND THE ATTENDING PHYSICIAN BELIEVED THE CAUSE OF DEATH WAS SEPSIS. OTHER FACTORS IN THE PATIENT'S DEATH INCLUDED NECROTIZING ENTEROCOLITIS, "MASSIVE" SMALL INTESTINAL RESECTION, SHORT BOWEL SYNDROME, AND TOTAL PARENTERAL NUTRITION. THE CUSTOMER STATED IT IS UNCLEAR WHETHER THE DISCONTINUATION OF VANCOMYCIN CONTRIBUTED TO THE PATIENT'S DEATH. THE RUN FILES WERE PROVIDED FOR THIS INVESTIGATION, HOWEVER, THE SAMPLE TYPE FOR EACH RUN WAS NOT SPECIFIED. THE ANALYSIS OF ONE OF THE BIOFIRE BCID2 PANEL RUN FILES SHOWED LATE AMPLIFICATION FOR THE E. FAECALIS ASSAY, SUGGESTING A LOW-LEVEL ORGANISM WAS PRESENT IN THE SAMPLE. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3JSL24 (KIT LOT# 2281924) 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 DESIGNED SPECIFICATIONS. BIOFIRE MEDICAL AFFAIRS ASSESSMENT: THE PATIENT'S BASELINE CHARACTERISTICS INDICATES A FRAGILE CLINICAL STATUS AND IMPLIES A HIGH RISK OF MORTALITY DUE TO BOTH THE UNDERLYING CONDITION AND REPEATED EPISODES OF SEPSIS. A CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION) OR AN ABDOMINAL SOURCE OF INFECTION MAY BE SUSPECTED AMONG OTHERS. BIOFIRE BCID2 PANEL RESULTS DETECTED K. PNEUMONIAE IN BOTH BLOOD SAMPLES - ONE DRAWN FROM A PERIPHERAL VENIPUNCTURE AND THE OTHER FROM THE CENTRAL VENOUS CATHETER - AND WERE CONCORDANT WITH THE GRAM STAIN, WHICH SHOWED GRAM-NEGATIVE ORGANISMS. A LATE AMPLIFICATION SIGNAL FOR E. FAECALIS WAS OBSERVED IN ONE SAMPLE. THIS MAY INDICATE VERY LOW LEVELS OF THE ORGANISM'S DNA OR BACKGROUND NOISE. ACCORDING TO THE BIOFIRE BCID2 INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048), THE PANEL MAY NOT DETECT ALL TARGETED ORGANISMS IN MIXED CULTURES, DEPENDING ON THE CONCENTRATION OF EACH TARGET. THE ABSENCE OF GRAM-POSITIVE ORGANISMS ON GRAM STAIN SUPPORTS THE HYPOTHESIS OF A POTENTIAL VERY LOW CONCENTRATION OF E. FAECALIS (DNA OR LIVING) IN BLOOD CULTURE BROTH TOGETHER WITH HIGHER CONCENTRATION OF KLEBSIELLA AT THE TIME OF TESTING. ADDITIONALLY, A FALSE POSITIVE RESULT FOR E. FAECALIS FROM THE MICROSCAN WALKAWAY SYSTEM CANNOT BE EXCLUDED UNTIL CONFIRMED BY OTHER METHODS. EVEN AFTER VANCOMYCIN IS DISCONTINUED, THERE IS A HIGH LIKELIHOOD OF THERAPEUTIC LEVELS OF VANCOMYCIN PERSISTING DUE TO THE REDUCED RENAL FUNCTION CAUSED BY SEPSIS. THE PATIENT DIED WITHIN ONE DAY OF THE DISCONTINUATION OF VANCOMYCIN AND, DEPENDING ON WHEN THE MOST RECENT VANCOMYCIN DOSE OCCURRED, THERAPEUTIC VANCOMYCIN LEVELS MAY HAVE STILL BEEN PRESENT THE FOLLOWING DAY. BASED ON THE AVAILABLE INFORMATION, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE WHETHER THE BIOFIRE BCID2 PANEL RESULTS CONTRIBUTED TO THE PATIENT'S DEATH. FURTHER CLINICAL AND LABORATORY DATA ARE NEEDED. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE E. FAECALIS RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE BIOFIRE BCID2 PANEL AND OTHER METHODS WITHIN POLYMICROBIAL BLOOD CULTURES. THE ANALYSIS OF THE BIOFIRE BCID2 PANEL RUN FILES PROVIDED BY THE CUSTOMER SUGGESTS THAT THE BLOOD CULTURE BOTTLE WAS LIKELY DRIVEN TO POSITIVITY BY THE METABOLIC GROWTH OF A PRIMARY ORGANISM, K. PNEUMONIAE. THE SLOWER-GROWING ORGANISM, E. FAECALIS, WAS PRESENT WITHIN THE SAMPLE, BUT WAS UNABLE TO REACH A LEVEL THAT WOULD BE DETECTED BY THE BIOFIRE BCID2 PANEL. IN MIXED CULTURES, THE BIOFIRE BCID2 PANEL MAY NOT IDENTIFY ALL TARGETED ORGANISMS IN THE SPECIMEN, DEPENDING UPON THE CONCENTRATION OF EACH TARGET PRESENT. THE BIOFIRE BCID2 PANEL IS A HIGHLY SENSITIVE, QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED DIAGNOSTIC TEST INTENDED TO DETECT MULTIPLE BACTERIAL, AND YEAST NUCLEIC ACIDS DIRECTLY FROM BLOOD CULTURE SAMPLES. THE BIOFIRE BCID2 PANEL IS HIGHLY SENSITIVE AND SPECIFIC AND THERE CAN BE DISCREPANCIES BETWEEN IT AND TRADITIONAL IDENTIFICATION METHODS. WHILE UNCOMMON, DISCREPANCIES BETWEEN THE BIOFIRE BCID2 PANEL AND TRADITIONAL METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT OBSERVED IN THE FIELD. IT WAS IDENTIFIED DURING THE INVESTIGATION THAT THE CUSTOMER TESTED DIFFERENT BLOOD CULTURE BOTTLES. RESULTS FROM DIFFERENT SAMPLES TESTED MAY NOT BE DIRECTLY COMPARABLE TO EACH OTHER. SAMPLE-TO-SAMPLE VARIABILITY BETWEEN COLLECTION EVENTS CAN INCLUDE FACTORS SUCH AS THE DIFFERENCES IN ORGANISM CONCENTRATION. CONSEQUENTLY, COMPARING TWO OR MORE DIFFERENT SAMPLES OR RESULTS FROM DIFFERENT COLLECTION EVENTS TO EACH OTHER IS NOT RECOMMENDED BY BIOFIRE AS RESULTS MAY NOT BE REPRODUCIBLE. ADDITIONALLY, IT WAS IDENTIFIED THAT THE PATIENT RECEIVED ANTIBIOTIC THERAPY FROM (B)(6) 2025, THROUGH (B)(6) 2025. IT SHOULD BE NOTED THAT THE PERFORMANCE OF THE BIOFIRE BCID2 PANEL HAS NOT BEEN ESTABLISHED FOR MONITORING THE TREATMENT OF INFECTION, AND TEST RESULTS MAY ALSO BE AFFECTED BY CONCURRENT ANTIBACTERIAL/ANTIFUNGAL THERAPY. THE "LIMITATIONS" SECTION OF THE BIOFIRE BCID2 PANEL IFU INCLUDES INFORMATION REGARDING FALSE NEGATIVE RESULTS. A NEGATIVE BIOFIRE BCID2 PANEL RESULT DOES NOT EXCLUDE THE POSSIBILITY OF BLOODSTREAM INFECTION. NEGATIVE RESULTS SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER MANAGEMENT DECISIONS. NEGATIVE TEST RESULTS MAY OCCUR FROM SEQUENCE VARIANTS IN THE REGION TARGETED BY THE ASSAY, THE PRESENCE OF INHIBITORS, TECHNICAL ERROR, SAMPLE MIX-UP, OR AN INFECTION CAUSED BY AN ORGANISM NOT DETECTED BY THE PANEL. TEST RESULTS MAY ALSO BE AFFECTED BY LEVELS OF ORGANISM IN THE SAMPLE THAT ARE BELOW THE LIMIT OF DETECTION FOR THE TEST (ESPECIALLY IN THE CASE OF MIXED CULTURES). BIOFIRE RECOMMENDS THAT RESULTS FROM THE BIOFIRE BCID2 PANEL SHOULD BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. ASIDE FROM THE DISCREPANCY, THE CUSTOMER MENTIONED THAT A SAFETY CABINET WAS USED AND WAS DECONTAMINATED WITH ALCOHOL AFTER EACH USE. BIOFIRE RECOMMENDS DECONTAMINATING IN BETWEEN SPECIMENS WITH A SUITABLE DISINFECTANT (E.G. 10% BLEACH) TO REDUCE THE RISK OF CROSS-CONTAMINATION. BIOFIRE RECOMMENDS CUSTOMERS DECONTAMINATE ALL WORK SURFACES USED OR INVOLVED IN FILMARRAY TESTING INCLUDING BIO-SAFETY CABINET SURFACES, POUCH LOADING STATIONS, FILMARRAY INSTRUMENTS, AND/OR TOUCH SURFACES (E.G., MONITORS, KEYBOARDS, DRAWERS, ETC.). CAREFUL ADHERENCE TO THE SAMPLE PROCESSING STEPS DESCRIBED IN THE BIOFIRE BCID2 PANEL'S IFU AND "CONTAMINATION PREVENTION AND DECONTAMINATION" TECHNICAL NOTE [FLM1-PRT-0230] IS RECOMMENDED TO AVOID POSSIBLE CONTAMINATION. CLINICAL PERFORMANCE CAN BE FOUND IN TABLE 27 OF THE BIOFIRE BCID2 PANEL IFU (WWW.ONLINE-IFU.COM/ITI0048).

Description of Event or Problem · 0

SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL RESULT (K. PNEUMONIAE DETECTED), THE PATIENT'S VANCOMYCIN TREATMENT WAS DISCONTINUED, AND TREATMENT WAS CHANGED TO CEFOTAXIME. THE CUSTOMER REPORTED THAT THE PATIENT DIED OF SEPSIS. BIOFIRE MEDICAL AFFAIRS TEAM IS CURRENTLY ASSESSING THIS CASE. BIOFIRE HAS ALSO 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.

Description of Event or Problem · 0

SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING PATIENT BLOOD CULTURE SAMPLES. DUE TO THE BIOFIRE BCID2 PANEL RESULT (K. PNEUMONIAE 'DETECTED', E. FAECALIS 'NOT DETECTED'), THE PATIENT'S VANCOMYCIN TREATMENT WAS DISCONTINUED, AND TREATMENT WAS CHANGED TO CEFOTAXIME. THE CUSTOMER REPORTED THAT THE PATIENT DIED OF SEPSIS. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE E. FAECALIS RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE BIOFIRE BCID2 PANEL AND OTHER METHODS WITHIN POLYMICROBIAL BLOOD CULTURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1674063	BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL	BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL	PEN	BIOFIRE DIAGNOSTICS, LLC	RFIT-ASY-0147	2281924	00815381020338

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 MO	Male	Death