BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® BPA US CULTURE BOTTLE

    MDR report key: 8729446 · Received June 24, 2019

    Report

    Report Number
    3002769706-2019-00017
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Report Date
    April 6, 2020
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    UDI-DI
    03573026611316
    PMA / PMN Number
    BK170142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278, LOT 1053208). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. IN RESPONSE TO THE CUSTOMER COMPLAINT BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. THE INVESTIGATION EXAMINED THE BACT/ALERT® BPA BOTTLE MANUFACTURING RECORDS FOR LOT 1053208, THE COMPLAINT DATA, AND DIRECTIONS IN THE BOTTLE INSTRUCTIONS FOR USE [IFU]. THE LOT MET ALL RELEASE SPECIFICATIONS AND QUALITY ASSURANCE RELEASED THE LOT FOR DISTRIBUTION TO THE FIELD ON 26MAR19. A REVIEW OF THE BOTTLE IFU FOUND SUFFICIENT GUIDANCE REGARDING TESTING OF BOTTLES. HISTORICAL REVIEW OF COMPLAINT DATA DETERMINED NO ADVERSE TREND FOR FALSE POSITIVE COMPLAINTS IN THE BACT/ALERT BPA BOTTLE TYPE OR IN LOT 1053208. THE LOT EXPIRED 26FEB20. THE ROOT CAUSE FOR THE INSTRUMENT FALSE POSITIVE RESULTS COULD NOT BE DETERMINED AS THE SPECIFIC BOTTLE DATA WAS NOT FOUND IN THE BACKUPS PROVIDED BY THE CUSTOMER. THE MOST PROBABLE ROOT CAUSES FOR THE FALSE POSITIVES OBSERVED INCLUDE THE CUSTOMER'S LOADING PATTERN, INOCULATION LEUKOCYTE CONCENTRATION, AS WELL AS POWER OUTAGE, AND/ OR COMMUNICATION LOSS TO THE INSTRUMENT. THERE IS NO EVIDENCE WHICH SUGGESTS THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278, LOT 1053208) IS NOT FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521081 BACT/ALERT® BPA US CULTURE BOTTLE BACT/ALERT® BPA US CULTURE BOTTLE MZC BIOMERIEUX INC. 1053208 03573026611316

    Patients

    Seq Age Sex Outcome Treatment
    1