BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT MP CULTURE BOTTLES

    MDR report key: 980268 · Received December 20, 2007

    Report

    Report Number
    3002769706-2007-00008
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 14, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACT/ALERT MP PROCESS SYSTEM CONSISTS 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. THE CUSTOMER HAS DISCONTINUED USE OF THE PRECISE-QTB PRODUCT.

    Description of Event or Problem · 1

    INOCULATED BACT/ALERT MP PLASTIC BOTTLES REMOVED FROM THE INCUBATOR HAD "CRACKS" AROUND THE NECK OF THE BOTTLE WHERE IT HAD BEEN CLEANED WITH THE DISINFECTANT PRECISE QTB (CALTECH). ON ONE BOTTLE WHICH HAD TESTED NEGATIVE, THE INTEGRITY OF THE BOTTLE HAD BEEN COMPROMISED, AND IT LEAKED A SMALL AMOUNT THAT CAUSED THE BOTTLE TO STICK TO THE INSTRUMENT CELL. THE CUSTOMER FOLLOWED THEIR LAB PROCEDURE FOR CLEAN-UP OF THE SPILL. THE LAB HAS DISCONTINUED THE USE OF PRECISE-QTB. THERE WAS NO PT OR RESULTS IMPACT DUE TO THIS ISSUE, NOR WAS THERE ANY DEATH OR INJURY RELATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT MP CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 259797 1016249

    Patients

    Seq Age Sex Outcome Treatment
    1