BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACTEC PLUS AEROBIC/F CULTURE VIAL

    MDR report key: 277263 · Received May 12, 2000

    Report

    Report Number
    1119779-2000-00002
    Event Type
    Death
    Date Received
    May 12, 2000
    Date of Event
    April 11, 2000
    Report Date
    April 12, 2000
    Manufacturer
    BECTON DICKINSON
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVES OF INOCULATED CULTURE MEDIA WHILE USING A BACTEC INSTRUMENT. TWO CULTURE VIALS WERE INOCULATED AND REPORTED AS FALSE NEGATIVES FOR THE SAME SPECIMEN; THIS DEVICE (BACTEC PLUS AEROBIC/F CULTURE VIAL) AND A BACTEC LYTIC/ANAEROBIC/F CULTURE VIAL, CATALOG #442265, LOT# 9322701. THE MFG DATE FOR THE LYTIC VIAL WAS 11/20/1999 AND THE EXPIRATION DATE IS 09/01/2000. VIALS WERE SUBCULTURED AND IDENTIFIED AS GROUP B STREPTOCOCCI. THE PT LATER DIED FROM THE EFFECTS OF MENINGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC PLUS AEROBIC/F CULTURE VIAL CULTURE MEDIA JTA BECTON DICKINSON NA 9315701

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Death