BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA CULTURE BOTTLE

    MDR report key: 8864489 · Received August 6, 2019

    Report

    Report Number
    3002769706-2019-00027
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    March 18, 2020
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026055820
    PMA / PMN Number
    K020813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. THE INVESTIGATION INCLUDED A REVIEW OF MANUFACTURING RECORDS AND A REVIEW OF THE INSTRUCTIONS FOR USE (IFU). NO EVIDENCE WAS FOUND IN THE MANUFACTURING RECORD REVIEW TO SHOW A PROBLEM WITH CONTAMINATION OF BOTTLES. THE BATCH MET ALL RELEASE CRITERIA AND QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD. EVALUATION OF COMPLAINTS SHOWED NO ADVERSE TREND IS PRESENT IN THE COMPLAINT DATA FOR INOCULATED BOTTLE CONTAMINATION INVOLVING THE FOLLOWING ORGANISMS: BACILLUS, PAENIBACILLUS, AND STAPHYLOCOCCUS. THE REVIEW OF THE BOTTLE IFU FOUND THE IFU CONTAINS SUFFICIENT DIRECTIONS FOR CLEANING THE BOTTLE STOPPER, AND AVOIDANCE OF CONTAMINATING THE BOTTLE DURING INOCULATION. THERE IS NO EVIDENCE FOUND AT THE TIME OF THIS INVESTIGATION, THAT THE SOURCE FOR THIS CUSTOMER'S COMPLAINT IS CONTAMINATION OF THE BOTTLE BY THE MANUFACTURER PRIOR TO USE BY THE CUSTOMER. THE MOST LIKELY ROOT CAUSE IS CONTAMINATION AT THE TIME OF INOCULATION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF RECOVERING BACILLUS SPECIES WHEN TESTING WITH BACT/ALERT® SA BOTTLES (LOTS 1052576, 1053278 AND 1053002), BACT/ALERT SN BOTTLES (LOTS 1053350, 1052950 AND 1053162) AND BACT/ALERT FA BOTTLES (LOT 1053482). THE CUSTOMER REPORTED THAT THE SUSPECTED CONTAMINATION OF BACILLUS WAS OBTAINED FOR MULTIPLE PATIENTS. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. THE CUSTOMER REPORTED THE PHYSICIAN SUSPECTED THE RESULTS WERE CONTAMINATION. NO PATIENT WAS TREATED FOR BACILLUS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657531 BACT/ALERT® FA CULTURE BOTTLE BACT/ALERT® FA CULTURE BOTTLE MDB BIOMERIEUX INC. 1053482 03573026055820

    Patients

    Seq Age Sex Outcome Treatment
    1