BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® 3D

    MDR report key: 5351188 · Received January 7, 2016

    Report

    Report Number
    1950204-2016-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    November 25, 2015
    Report Date
    November 27, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K903505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMERIEUX CONDUCTED AN INVESTIGATION INTO A REPORTED INCIDENT IN WHICH THE BACT/ALERT® 3D INSTRUMENT MAY NOT HAVE DETECTED A POSITIVE BOTTLE. THE INSTRUMENT DATA BACKUP WAS ANALYZED. ANALYSIS OF THE BOTTLE READINGS REVEALED THAT THE BACT/ALERT® SA CULTURE BOTTLE DID NOT SHOW EVIDENCE OF HAVING ENOUGH OF A REFLECTANCE CHANGE IN ORDER TO FLAG THE BOTTLE AS POSITIVE. INTERVIEW WITH THE CUSTOMER REVEALED THAT THE BOTTLE SUBCULTURE WAS POSITIVE FOR PROTEUS MIRABILIS, A FACULTATIVE ANAEROBIC ORGANISM. THE BACT/ALERT® SA CULTURE BOTTLE IS INTENDED FOR USE AND TO GROW AEROBIC ORGANISMS. THEREFORE, THIS ORGANISM IS BETTER TO BE GROWN IN THE BACT/ALERT® SN CULTURE BOTTLE. BASED ON THE INVESTIGATION RESULTS, THE INSTRUMENT APPEARS TO BE OPERATING AS INTENDED. ADDITIONALLY, PER THE BACT/ALERT® SA CULTURE BOTTLE PACKAGE INSERT, "CAUTION: ON RARE OCCASIONS ORGANISMS MAY BE ENCOUNTERED THAT GROW IN THE BACT/ALERT SA CULTURE BOTTLE GROWTH MEDIA BUT DO NOT PRODUCE SUFFICIENT CARBON DIOXIDE TO BE DETERMINED POSITIVE."

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A DISCREPANT RESULT ASSOCIATED WITH A PATIENT SAMPLE WITH THE BACT/ALERT 3D INSTRUMENT. THE CUSTOMER NOTICED THAT THE BOTTLE HAD SIGNS OF MICROBIAL GROWTH UPON UNLOADING FROM THE INSTRUMENT AND THEREFORE PERFORMED A SUBCULTURE. THE CULTURE BOTTLE HAD A FINAL INSTRUMENT DETERMINATION OF NEGATIVE; HOWEVER UPON TERMINAL SUBCULTURE, THE RESULT WAS POSITIVE. AN INTERNAL INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO DETERMINE THE CAUSE OF THIS DISCREPANT RESULT. WHEN REQUESTED TO PROVIDE SPECIFIC DETAILS REGARDING THE INCIDENT, THE CUSTOMER INDICATED NO DEATH NOR INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11056 BACT/ALERT® 3D BLOOD CULTURE SYSTEM MDB BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1