BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    MDR report key: 19746710 · Received July 15, 2024

    Report

    Report Number
    3002773840-2024-00364
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K193519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SCIENTIFIC LITERATURE PRODUCED BY NORTHWELL HEALTH () TITLED: "POTENTIAL FALSE POSITIVE CANDIDA TROPICALIS BIOFIRE BCID2 RESULTS WHEN USING BD BACTEC BLOOD CULTURE BOTTLES" BY NOBLE ET. AL ALLEGES MULTIPLE C. TROPICALIS FALSE POSITIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRING IN 2021-2023. THE NUMBER OF PATIENTS INVOLVED, PATIENT IMPACT, AND PRODUCT INFORMATION (E.G., RUN FILE AND LOT INFORMATION) ARE UNKNOWN. THERE WAS NO ALLEGATION OF SERIOUS INJURY OR DEATH DUE TO THE C. TROPICALIS RESULTS. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT C. TROPICALIS 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 BD BACTEC¿ BLOOD CULTURE BOTTLES. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED IN THE U.S. ON JANUARY 26, 2024, AND COUNTRIES OUTSIDE U.S. ON JANUARY 30, 2024, VIA FSCA #5811 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 38. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, CANDIDA SPP. OF THE BIOFIRE BCID2 PANEL IFU, THE PERFORMANCE CLAIM FOR THE C. TROPICALIS ASSAY COMPARED TO STANDARD OF CARE IDENTIFICATION FOR GENUS LEVEL FOLLOWED BY PCR & SEQUENCING OF ISOLATES FOR SPECIES IDENTIFICATION SHOWED AN OVERALL SENSITIVITY OF 100% (95% CI 93.5-100%) AND AN OVERALL SPECIFICITY OF 99.9% (95% CI 99.7-100%). THE SINGLE FALSE POSITIVE SPECIMEN WAS IDENTIFIED AS A CROSS-REACTIVITY BETWEEN THE BIOFIRE BCID2 PANEL C. TROPICALIS ASSAY AND HIGH TITER CANDIDA PARAPSILOSIS. THIS CROSS-REACTIVITY IS A KNOWN LIMITATION OF THE BIOFIRE BCID2 PANEL.

    Description of Event or Problem · 0

    SUMMARY: BIOFIRE WAS MADE AWARE OF SCIENTIFIC LITERATURE PRODUCED BY NORTHWELL HEALTH (NEW HYDE PARK, NY) TITLED: "POTENTIAL FALSE POSITIVE CANDIDA TROPICALIS BIOFIRE BCID2 RESULTS WHEN USING BD BACTEC BLOOD CULTURE BOTTLES" BY NOBLE ET. AL WHICH ALLEGED MULTIPLE C. TROPICALIS FALSE POSITIVE RESULTS ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRING IN 2021-2023. THE NUMBER OF PATIENTS INVOLVED, PATIENT IMPACT, AND PRODUCT INFORMATION (E.G., RUN FILE AND LOT INFORMATION) ARE UNKNOWN. BIOFIRE HAS REACHED OUT TO THE AUTHORS FOR ADDITIONAL DETAIL, HOWEVER NO INFORMATION HAS BEEN RECEIVED TO DATE. BIOFIRE WILL SUBMIT A FOLLOW-UP REPORT IN THE EVENT THAT FURTHER INFORMATION IS RECEIVED. BASED ON HISTORICAL FIELD DATA AND TREND DATA, THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT C. TROPICALIS 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
    2506710 BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown