BEUDAMED
    FDA Adverse Event Summary report: N

    SEPTI-CHEK BROTH

    MDR report key: 11388 · Received February 3, 1994

    Report

    Report Number
    MW4000169
    Date Received
    February 3, 1994
    Report Date
    January 26, 1994
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSC
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BELIEVE THE PRODUCT IS CONTAMINATED WITH MAI BACTERIA. OBTAINED FALSE POSITIVE RESULTS IN PTS; ONLY 2 OUT OF 8 WERE ACTUAL NONCONTAMINANTS. TESTED ALL MATERIALS IN USE AND NO CONTAMINATION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPTI-CHEK BROTH JSC BECTON DICKINSON MICROBIOLOGY SYSTEMS B46NAX, 53401, 1000LEGLGX

    Patients

    Seq Age Sex Outcome Treatment
    1 *