BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    MDR report key: 18060433 · Received November 2, 2023

    Report

    Report Number
    3002773840-2023-00003
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K193519
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT NO SERIOUS INJURY OR DEATH OCCURRED BUT WE ARE REPORTING BECAUSE THE CUSTOMER STATED THEY REPORTED TO THE FDA. INVESTIGATION: THE PATIENT WAS A 78-YEAR-OLD MALE WHO PRESENTED WITH SIGNS/SYMPTOMS OF ALTERED MENTAL STATUS AND SEPSIS AT THE TIME OF TESTING. ON (B)(6), 2023, A PATIENT'S BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED C. TROPICALIS, MECA/C, STAPHYLOCOCCUS EPIDERMIS, AND STAPHYLOCOCCUS SPP. AS DETECTED. GRAM-POSITIVE COCCI IN CLUSTERS WERE OBSERVED ON GRAM STAIN AND THERE WAS GROWTH OF S. EPIDERMIDIS FROM CULTURE OF THE SAME SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT WAS TREATED WITH FLUCONAZOLE (UNKNOWN FOR HOW LONG). THE CUSTOMER STATED THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE SIDE EFFECTS DUE TO THE INAPPROPRIATE TREATMENT. THE FINAL DIAGNOSIS OF THE PATIENT WAS SEPSIS. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 2VHS23 (KIT LOT# 1379123) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AND THE FILMARRAY INSTRUMENT (SERIAL NUMBER# (B)(6)) WAS WORKING WITHIN DESIGNED SPECIFICATIONS. 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. CUSTOMERS WERE NOTIFIED OF THIS ISSUE VIA CUSTOMER SERVICE NOTIFICATION REFERENCE#: (B)(4). 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 BIOFIRE BCID2 PANEL IS WORKING AS INTENDED. 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: (B)(6) HOSPITAL REPORTED A POTENTIAL FALSE POSITIVE CANDIDA TROPICALIS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT WAS TREATED WITH FLUCONAZOLE (UNKNOWN FOR HOW LONG). THE CUSTOMER STATED THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE SIDE EFFECTS DUE TO THIS INAPPROPRIATE TREATMENT. THE CUSTOMER ALSO REPORTED THIS INCIDENT TO THE FDA (REFERENCE NUMBER UNKNOWN). UPON INVESTIGATION, NO MALFUNCTION OCCURRED, AND THE BIOFIRE BCID2 PANEL WAS WORKING WITHIN SPECIFICATION. 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. PLEASE NOTE THAT NO SERIOUS INJURY OR DEATH OCCURRED BUT WE ARE REPORTING BECAUSE THE CUSTOMER STATED THEY REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209359 BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 1379123 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male