BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT PF BOTTLE

    MDR report key: 496452 · Received August 22, 2003

    Report

    Report Number
    1039284-2003-00005
    Event Type
    Malfunction
    Date Received
    August 22, 2003
    Date of Event
    June 16, 2003
    Report Date
    August 22, 2003
    Manufacturer
    BIOMERIEUK, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD CULTURE DRAWN & DELIVERED TO THE HOSPITAL LABORATORY WITHIN 30 MINUTES. THE BOTTLE FLAGGED POSITIVE 2 HOURS. CUSTOMER CONCERNED THAT THE BOTTLE WAS CONTAMINATED. LAB SCIENCISTS IDENTIFIED THE ORGANISM AS DIPHTHEROID. A PATIENT WAS ADMITTED AND PROBABLY TREATED BASED ON THE RESULTS. CUSTOMER DID NOT NOTICE ANY CRACKS IN THE BOTTLE & IT DID NOT APPEAR DAMAGED OR DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT PF BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUK, INC. * 208792

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Hospitalization