BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT PF BOTTLE

    MDR report key: 512560 · Received February 23, 2004

    Report

    Report Number
    3002769706-2004-00001
    Event Type
    Injury
    Date Received
    February 23, 2004
    Date of Event
    January 19, 2004
    Report Date
    February 18, 2004
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED STATING THAT A PT WAS SEEN IN THE EMERGENCY ROOM AFTER A FEBRILE CONVULSION. THE CULTURE FLAGGED POSITIVE WITH A GNB, THE ER DOCTORS ADMITTED THE PT TO THE HOSP AND STARTED PT ON IV ANTIBIOTICS. THE CUSTOMER IS ALLEGING THAT THE SUBCULTURE REVEALED BACILLUS AND THAT THE BOTTLE WAS CONTAMINATED PRIOR TO INOCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT PF BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. UNK 208574

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization