BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT PF BOTTLE

    MDR report key: 496468 · Received November 14, 2003

    Report

    Report Number
    1039284-2003-00004
    Event Type
    Malfunction
    Date Received
    November 14, 2003
    Date of Event
    March 24, 2003
    Report Date
    August 14, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOSP LAB NOTICED PF BOTTLES FROM THE SAME LOT WERE POSITIVE IMMEDIATELY UPON LOADING INTO THE INSTRUMENT. PRIOR TO FINDING THESE BOTTLES A PT SPECIMEN WAS RUN AND WAS POSITIVE FOR BACILLUS. THE PT WAS HOSPITALIZED AND TREATED DUE TO THE POSITIVE BOTTLE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT PF BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. * 208790

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization