BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACT/ALERT MP CULTURE BOTTLES

    MDR report key: 871867 · Received June 26, 2007

    Report

    Report Number
    3002769706-2007-00004
    Event Type
    Other
    Date Received
    June 26, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 22, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACT/ALERT MP PROCESS SYSTEM CONSIST OF THE BACT/ALERT MP PROCESS BOTTLE WITH A REMOVABLE CLOSURE USED IN CONJUNCTION WITH THE MB/BACT/ALERT ANTIBIOTIC SUPPLEMENT (AND /OR THE MB/BACT/ALERT 3D MYCOBACTERIA DETECTION SYSTEMS FOR THE RECOVERY AND DETECTION OF MYCOBACTERIA FROM STERILE BODY SPECIMENS OTHER THAN BLOOD) AND FROM DIGESTED-DECONTAMINATED CLINICAL SPECIMENS. THERE IS A POTENTIAL FOR AN ADVERSE EVENT WERE THIS TO RECUR AND THE INTEGRITY OF A POSITIVE BOTTLE WERE TO BE COMPROMISED. IN THE EVENT OF BREAKAGE, THE USER COULD BE EXPOSED TO AEROSOLIZED MYCOBACTERIA SAMPLES THAT CAN HAVE SIGNIFICANT HEALTH EFFECTS. CURRENTLY, THIS ISSUE IS SPECIFIC TO THIS CUSTOMER ONLY THE CUSTOMER INDICATED THAT THEY RECENTLY CHANGED THE DISINFECTANT USED IN THERE PROCESSING OF BOTTLES. THEY HAD NOT NOTICED THIS ISSUE OF CRACKED BOTTLES PRIOR TO THE CHANGE IN DISINFECTANT. THEREFORE, BIOMERIEUX IS INVESTIGATING THE INTERACTION OF THIS DISINFECTANT WITH THE MP BOTTLE AS PART OF THE OVERALL INVESTIGATION INTO THIS COMPLAINT.

    Description of Event or Problem · 1

    INOCULATED BACT/ALERT MP PLASTIC BOTTLES REMOVED FROM THE INCUBATOR HAD "CRACKS" AROUND THE NECK OF THE BOTTLES. IT DOES NOT APPEAR THAT THE INTEGRITY OF THE BOTTLES HAD BEEN COMPROMISED, BUT SOME OF THE BOTTLES FLAGGED POSITIVE. CUSTOMER INDICATED THAT THEY FOUND NO INOCULATED BOTTLES WITH CRACKS PRIOR TO LOADING NOR DURING AN INSPECTION OF UNINOCULATED BOTTLES. THERE WAS NO PT OR RESULTS IMPACT DUE TO THIS ISSUE NOR WAS THERE ANY DEATHS OR INJURIES RELATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT MP CULTURE BOTTLES MICROBIAL GROWTH MONTIOR MDB BIOMERIEUX, INC. 259797 1015498,1015712

    Patients

    Seq Age Sex Outcome Treatment
    1 YR