BEUDAMED
    FDA Adverse Event Summary report: N

    BACTEC 12 B MEDIUM

    MDR report key: 28597 · Received December 8, 1995

    Report

    Report Number
    MW1007891
    Date Received
    December 8, 1995
    Date of Event
    July 1, 1995
    Report Date
    December 7, 1995
    Manufacturer
    DIAGNOSTIC INSTRUMENT DIV. BECTON DICKINSON CORP.
    Product Code
    JSD
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RPTR HAS NOTICED A 4-FOLD INCREASE IN CARBON 14 BACKGROUNDS OVER THE LAST 4-6 MONTHS. USER IS CONCERNED DUE TO OVERALL TREND, EVEN THOUGH LEVELS ARE WITHIN MFR'S SPECS. USER HAS RULED OUT ANALYZER AS SOURCE OF PROBLEM AND IS CONCERNED THAT TESTS INDICATE SUBSTRATE BREAKING DOWN. NO DIRECT INFECTION CONTROL ISSUE AT THIS TIME. USER IS CONCERNED OVER MFR'S APPARENT LACK OF CONCERN OVER TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC 12 B MEDIUM TB MYOBACTERIUM BROTH MEDIUM JSD DIAGNOSTIC INSTRUMENT DIV. BECTON DICKINSON CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *