BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFIRE BCID2 PANEL

    MDR report key: 24782709 · Received April 3, 2026

    Report

    Report Number
    3002773840-2026-00007
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K243759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE PATIENT WAS AN 84-YEAR-OLD FEMALE WITH "COMPLEX MEDICAL HISTORY INCLUDING AORTIC STENOSIS S/P PROSTHETIC AORTIC VALVE REPLACEMENT, HFPEF, COPD, SCC S/P CHEMO/RT, AND R BREAST CA S/P MASTECTOMY." ON (B)(6), 2026, THE PATIENT WAS ADMITTED WITH FEVER AND SUSPECTED OF PNEUMONIA. THE PATIENT WAS STARTED ON EMPIRIC CEFTRIAXONE AND AZITHROMYCIN. ON (B)(6) 2026, THE PATIENT'S BLOOD CULTURE SAMPLE WAS TESTED ON THE BCID2 PANEL. THE BCID2 PANEL REPORTED STAPHYLOCOCCUS SPP. AND STAPHYLOCOCCUS AUREUS AS DETECTED. THE SAME SAMPLE WAS REPEATED ON THE BCID2 PANEL ON (B)(6), 2026, AND ALSO REPORTED STAPHYLOCOCCUS SPP. AND STAPHYLOCOCCUS AUREUS AS DETECTED. MECA/C AND MREJ WERE REPORTED AS NOT DETECTED BOTH TIMES. THE CUSTOMER STATED THAT THE PATIENT'S ANTIBIOTIC WAS CHANGED TO CEFEPIME ON (B)(6), 2026, AND THEN TO CEFAZOLIN ON (B)(6), 2026, FOR BETTER MSSA COVERAGE. ON UNKNOWN DATES, THE CUSTOMER RECEIVED THE GRAM-POSITIVE COCCI IN CLUSTERS ON GRAM STAIN, A CEPHEID ¿MRSA DETECTED¿ RESULT, A BRUKER MALDI MS ¿MRSA¿ RESULT AND AN UNKNOWN BRAND STRIP TEST MRSA RESULT. WHEN AST WAS POSITIVE FOR MRSA ON (B)(6), 2026, VANCOMYCIN TREATMENT WAS INITIATED FOR THE PATIENT. THE CUSTOMER REPORTED THAT THE ISOLATED S. AUREUS STRAIN WAS SUSCEPTIBLE TO VANCOMYCIN. THE CUSTOMER STATED REPEAT BLOOD CULTURES FROM (B)(6), 2026, AND (B)(6) 2026, WERE POSITIVE FOR MRSA AND THE RESULTS OF THE REPEAT BLOOD CULTURES FROM (B)(6), 2026, WERE PENDING. THE BCID2 AND CULTURE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT WAS GIVEN A FINAL DIAGNOSIS OF "COMPLEX MEDICAL HISTORY; BEING TREATED FOR SEPSIS CAUSED BY MRSA COMPLICATED BY INAPPROPRIATE ANTIMICROBIAL COVERAGE FOR 2 DAYS DUE TO FALSE NEGATIVE BIOFIRE BCID2 RESULT." THE CUSTOMER REPORTED THAT DUE TO THE BCID2 PANEL RESULT, THE PATIENT DID NOT RECEIVE APPROPRIATE MRSA COVERAGE FOR 2 FULL DAYS FROM THE TIME S. AUREUS WAS IDENTIFIED ON (B)(6), 2026. ON (B)(6), 2026, WHEN ASKED WHETHER THE PATIENT WAS HARMED OR IF THEIR CONDITION DETERIORATED DUE TO THE CHANGE IN TREATMENT, THE CUSTOMER STATED THAT IT WAS HARD TO KNOW FOR SURE. THE PATIENT REMAINED HOSPITALIZED IN SERIOUS CONDITION AND HAD NOT CLEARED MRSA BACTEREMIA. THEY STATED IT WAS DIFFICULT TO SAY IF DELAYING MRSA COVERAGE BY 2 DAYS CONTRIBUTED TO THIS, BUT IT CERTAINLY DID NOT HELP. IN AN ADDITIONAL COMMUNICATION ON MARCH 23, 2026, THE CUSTOMER STATED IT WAS UNKNOWN IF PATIENT DEVELOPED ANY METASTATIC INFECTIONS THAT COULD CONTRIBUTE TO PERSISTENT MRSA BACTEREMIA. WHEN ASKED WHAT WAS IDENTIFIED AS THE INITIAL SOURCE OF THE S. AUREUS BACTEREMIA AND IF SOURCE CONTROL HAD BEEN ACHIEVED, THE CUSTOMER STATED SOURCE CONTROL WAS NOT ACHIEVED AND THE PATIENT EXPIRED ON (B)(6), 2026, AS A RESULT OF SEPSIS AND MULTIORGAN FAILURE. THE CUSTOMER STATED THE PATIENT HAD A NON-DIAGNOSTIC TEE AND THE PATIENT DID HAVE A PROSTHETIC AORTIC VALVE WHICH COULD HAVE BEEN SEEDING THE BLOODSTREAM INFECTION. BIOFIRE MEDICAL AFFAIRS ASSESSMENT: BASED ON THE DATA PROVIDED, FALSE NEGATIVE BCID2 RESULT COULD POTENTIALLY CAUSE/CONTRIBUTE TO PATIENT SERIOUS INJURY, AS THE PATIENT WAS ULTIMATELY DIAGNOSED WITH SEPSIS CAUSED BY MRSA. HOWEVER, GIVEN THE COMPLEX, MULTIFACTORIAL NATURE OF PERSISTENT MRSAB AND PATIENT¿S COMORBIDITIES, THERAPEUTIC DELAY CANNOT BE CONCLUDED TO HAVE DIRECT CAUSALITY WITH THE PATIENT DEATH. INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. CONCLUSION: N/A FOR INITIAL REPORT.

    Description of Event or Problem · 0

    SUMMARY: (B)(6), NY) REPORTED A POTENTIAL FALSE NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A BLOOD CULTURE SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BCID2 RESULTS, THE PATIENT DID NOT RECEIVE APPROPRIATE MRSA COVERAGE FOR 2 FULL DAYS. THE PATIENT WAS HOSPITALIZED AND IN SERIOUS CONDITION. ON MARCH 5, 2026, THE CUSTOMER STATED IT WAS DIFFICULT TO SAY IF DELAYING MRSA COVERAGE BY 2 DAYS CONTRIBUTED TO THE PATIENT'S SERIOUS CONDITION, BUT IT CERTAINLY DID NOT HELP. ON MARCH 23, 2026, THE CUSTOMER STATED THAT THE PATIENT EXPIRED ON (B)(6) 2026, AS A RESULT OF SEPSIS AND MULTIORGAN FAILURE. INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498270 BIOFIRE BCID2 PANEL BIOFIRE BCID2 PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 2300225 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1