BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    MDR report key: 22030408 · Received May 15, 2025

    Report

    Report Number
    3002773840-2025-00038
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    March 23, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K193519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A POTENTIAL FALSE POSITIVE S. MARCESCENS RESULT ON THE BIOFIRE BCID2 PANEL WAS REPORTED AFTER TESTING A BLOOD CULTURE SAMPLE FROM AN 80-YEAR-OLD MALE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD NO CLINICAL HISTORY. ON (B)(6) 2025, AN INITIAL BLOOD SAMPLE WAS COLLECTED INTO ONE SET OF BLOOD CULTURE BOTTLES (BIOMERIEUX BACT/ALERT FA PLUS; LOT: 4102956; EXP: 2025/09/17 AND FN PLUS; LOT: 4062252; EXP: 2025/07/19). THE FA PLUS AND FN PLUS BOTTLES BOTH SIGNALED POSITIVE. THE FA PLUS POSITIVE BLOOD CULTURE (PBC) WAS TESTED ON THE BIOFIRE BCID2 PANEL ON THE SAME DAY, WHICH RESULTED IN S. MARCESCENS, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP., AND ENTEROBACTERALES AS DETECTED. STREPTOCOCCUS SANGUINIS WAS RECOVERED IN CULTURE. GRAM-POSITIVE COCCI IN PAIRS AND SHORT CHAINS WERE OBSERVED ON GRAM STAIN. ON (B)(6) 2025, A SECOND BLOOD SAMPLE WAS COLLECTED IN TWO SETS OF BLOOD CULTURE BOTTLES (BIOMERIEUX BACT/ALERT FN PLUS; LOT: 4062314; EXP: 2025/07/23). THE FN PLUS PBC WAS TESTED ON THE BIOFIRE BCID2 PANEL (KIT LOT: 1808824, DOM: 2024/08/18, EXP: 2025/08/12) ON APRIL 1, 2025. THE REPEAT RUN RESULTED IN C. AURIS, ENTEROBACTERALES, AND S. MARCESCENS AS DETECTED. NO GROWTH WAS OBSERVED IN CULTURE. THE CUSTOMER STATED THAT C. AURIS, S. SANGUINIS, AND S. MARCESCENS WERE REPORTED TO THE PHYSICIAN. THE PATIENT EXPIRED, HOWEVER, THE CUSTOMER CONFIRMED THE BIOFIRE BCID2 PANEL RESULT DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE. SIMILAR EVENTS WERE RECENTLY OBSERVED IN THE FIELD WITH THE COMBINATION OF THE BIOFIRE BCID2 PANEL AND SPECIFIC LOTS OF BACT/ALERT® CULTURE MEDIA BOTTLES. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED IN THE U.S. ON JUNE 7, 2024 VIA FSCA FA-TWD-000005. FSCA FA-TWD-000029, AN EXTENSION OF FSCA FA-TWD-000005, WAS ISSUED IN THE U.S. ON JANUARY 22, 2025, FOR THIS ISSUE. WHILE BLOOD CULTURE VIALS ARE AUTOCLAVED AND ROUTINELY QUALITY CONTROLLED FOR STERILITY, NON-VIABLE ORGANISMS OR NUCLEIC ACIDS CAN REMAIN IN THE BLOOD CULTURE MEDIA AFTER THE STERILIZATION PROCESS. THE PRESENCE OF NON-VIABLE ORGANISMS AND NUCLEIC ACID DOES NOT COMPROMISE THE INTENDED USE OF BLOOD CULTURE MEDIA, CULTURING VIABLE MICROORGANISMS; HOWEVER, THE BIOFIRE BCID2 PANEL DOES NOT DISTINGUISH BETWEEN NUCLEIC ACID FROM VIABLE OR NON-VIABLE ORGANISMS. THE "LABORATORY PRECAUTION" AND "LIMITATION" SECTIONS OF THE BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048) OUTLINES THE POTENTIAL FOR FALSE POSITIVE DETECTIONS DURING MOLECULAR TESTING WITH STERILE BLOOD CULTURE MEDIA CONTAINING DETECTABLE LEVELS OF NON-VIABLE ORGANISMS AND/OR NUCLEIC ACID. IMPORTANTLY, RESULTS FROM THE BIOFIRE BCID2 PANEL ARE INTENDED TO BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. ALL IDENTIFICATION RESULTS PROVIDED BY THE BIOFIRE BCID2 PANEL ARE INTENDED TO BE INTERPRETED IN CONJUNCTION WITH GRAM STAIN RESULTS. CLINICAL PERFORMANCE: ACCORDING TO TABLE 33. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, ENTEROBACTERALES OF THE BIOFIRE BCID2 PANEL IFU, THE PERFORMANCE CLAIM FOR THE S. MARCESCENS ASSAY COMPARED TO STANDARD MANUAL AND AUTOMATED MICROBIOLOGICAL/BIOCHEMICAL IDENTIFICATION METHODS SHOWED AN OVERALL SENSITIVITY OF 100% (95% CI 87.5-100%) AND AN OVERALL SPECIFICITY OF 100% (95% CI 99.7-100%).

    Description of Event or Problem · 0

    (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. THE PATIENT EXPIRED, HOWEVER, THE BIOFIRE BCID2 PANEL RESULT DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83862 BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 1778024 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male