BEUDAMED
    FDA Adverse Event Other Summary report: N

    GN 09

    MDR report key: 854949 · Received May 18, 2007

    Report

    Report Number
    MW5001916
    Event Type
    Other
    Date Received
    May 18, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 18, 2007
    Manufacturer
    BIOMERIEUX
    Product Code
    LTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE PERFORM MICROBIOLOGICAL CULTURES AND SENSITIVITIES AS PART OF ROUTING CLINICAL TESTING. ANTIBIOTIC SENSITIVES ARE PERFORMED ON BIOMERIEUX VITEK II. WE SENT A SPECIMEN POSITIVE FOR SHIGELLA SONNEI -GROUP D- TO OUR STATE BOARD OF HEALTH LAB FOR EPIDEMIOLOGICAL MONITORING. THEY REGULARLY RE-TEST THE ISOLATES FOR IDENTIFICATION AND SENSITIVITY. WE REPORTED THE SAMPLE AS SENSITIVE TO BACTRIM, WHICH IS THE MOST COMMON RESULT FOR THIS ORGANISM. THEIR SENSITIVITY RESULTS DID NOT MATCH OURS. THEIR TEST WAS PERFORMED ON ANOTHER INSTRUMENT PLATFORM. IT WILL BE DIFFICULT TO DETERMINE IF PREVIOUS LOTS OF THESE CARDS ARE INVOLVED BECAUSE WE WON'T BE ABLE TO RE-TEST THOSE ISOLATES. DATES OF USE: TWENTY THREE DAYS IN 2007. DIAGNOSIS OR REASON FOR USE: ISOLATE POSITIVE FOR SHIGELLA SONNEI, SENSITIVITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GN 09 VITEK II LTW BIOMERIEUX 106067210
    2 GN 13 VITEK II LTW
    3 GN 17 VITEK II LTW

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other