BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACTEC 9240 SYSTEM

    MDR report key: 290193 · Received August 14, 2000

    Report

    Report Number
    1119779-2000-00003
    Event Type
    Death
    Date Received
    August 14, 2000
    Date of Event
    July 14, 2000
    Report Date
    July 18, 2000
    Manufacturer
    BECTON DICKINSON
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE OF INOCULATED CULTURE MEDIA WHILE USING A BACTEC INSTRUMENT. THE PT LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC 9240 SYSTEM MONITOR, MICROBIAL GROWTH JTA BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death