BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® BPN

    MDR report key: 8383610 · Received March 1, 2019

    Report

    Report Number
    3002769706-2019-00005
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    January 23, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    UDI-DI
    03573026126735
    PMA / PMN Number
    BK050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOLLOWING A CUSTOMER REPORT OF A POTENTIAL FALSE NEGATIVE RESULT WHEN TESTING BLOOD CULTURE USING THE BACT/ALERT® BPN (REFERENCE: (B)(4) BLOOD CULTURE BOTTLE. A LOT NUMBER FOR THE BOTTLE WAS NOT PROVIDED THEREFORE A HISTORICAL REVIEW FOR THE SPECIFIC LOT IN QUESTION COULD NOT BE PERFORMED. A REVIEW OF BACT/ALERT® BPN BOTTLE COMPLAINTS WAS PERFORMED AND DETERMINED THERE WAS NO TREND OF FALSE NEGATIVE RESULTS FOR BACT/ALERT® BPN BOTTLES. THE BPN BOTTLE GRAPH SHOWED THE BOTTLE WAS READING THE CORRECT ALGORITHM (H ALGORITHM), AND NO INSTRUMENT FAULT CODES WERE PRESENT WHEN THE BOTTLE WAS LOADED. GLOBAL CUSTOMER SERVICE AND BIOMATH ALSO REVIEWED THE BACKUP DATA PROVIDED FROM THE CUSTOMER. THIS REVIEW SHOWED THE H ALGORITHM FLAGGED THE BOTTLE NEGATIVE; HOWEVER, A REVIEW OF THE REFLECTANCE CURVES SHOWED THE PRESENCE OF A SLOW GROWING ORGANISM INDICATING THE BOTTLE WAS TRULY POSITIVE. GLOBAL CUSTOMER SERVICE AND BIOMATH STATED THE H ALGORITHM IS NOT OPTIMAL FOR THE DETECTION OF SLOW GROWING ORGANISMS. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION ABOUT THE TESTING MATERIAL OR ORGANISM IDENTIFICATION. WITHOUT THIS INFORMATION ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT WHEN USING THE BACT/ALERT® BPN BOTTLE. THE BOTTLE (ID (B)(4)) WAS LOADED ON (B)(6) 2019 AND FLAGGED AS NEGATIVE ON (B)(6) 2019. THE BOTTLE WAS THEN UNLOADED (B)(6) 2019, AND THE CELL INDICATOR WAS OBSERVED AS YELLOW. THE GRAPH INDICATED GROWTH AND FINISHED OVER 4000. THE BOTTLE WAS SUBCULTURED AND CONTAINED FACULTATIVE ANAEROBIC GRAM NEGATIVE SPHERE BACILLI. THE LOCAL FIELD SERVICE ENGINEER (FSE) HAD PREVIOUSLY VISITED THE SITE AND CHECKED THE INSTRUMENT CONDITION AND FOUND NO ISSUE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176034 BACT/ALERT® BPN BACT/ALERT® BPN MZC BIOMERIEUX INC. 03573026126735

    Patients

    Seq Age Sex Outcome Treatment
    1