BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMERIEUX BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    MDR report key: 20108254 · Received August 29, 2024

    Report

    Report Number
    MW5159067
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    December 12, 2023
    Report Date
    August 23, 2024
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC.
    Product Code
    PEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS RESULTED IN 3 DAYS OF INAPPROPRIATE ANTIMICROBIAL THERAPY FOR BACTEREMIA. IN SUMMARY, BCID2 YIELDED RESULTS OF STAPHYLOCOCCUS AUREUS AND "MECA/C & MREJ NOT DETECTED" ON (B)(6) 2023. BCID2 RESULTS WERE REPORTED TO THE ELECTRONIC MEDICAL RECORD THE SAME DAY. PHENOTYPIC ANTIMICROBIAL SUSCEPTIBILITY TESTING RESULTS (AGAR DILUTION), REPORTED ON (B)(6) 2023, YIELDED OXACILLIN MIC 2 MCG/ML (RESISTANT). MECA PCR PERFORMED BY A DIFFERENT MOLECULAR METHOD ON THE SUBCULTURED ISOLATE DETECTED MECA ON (B)(6) 2023. ON (B)(6) 2023, THE BCID2 RESULT WAS REVISED IN THE ELECTRONIC MEDICAL RECORD TO INDICATE THAT THE ISOLATE WAS MECA-POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910752 BIOMERIEUX BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS PEN BIOFIRE DIAGNOSTICS, LLC. 2282423

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| O