BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT SA

    MDR report key: 589107 · Received April 4, 2005

    Report

    Report Number
    3002769706-2005-00011
    Event Type
    Death
    Date Received
    April 4, 2005
    Date of Event
    March 21, 2005
    Report Date
    March 30, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE BACT SA IS A MICROBIAL MONITOR. A BACT SA BOTTLE SAMPLE CONTAINED PSEUDOMONAS AERUGINOSA WITH CONFIRMED GROWTH IN SUBCULTURE. AFTER 5 DAYS IN THE BACT INSTRUMENT, THE INSTRUMENT DID NOT INDICTE THE BOTTLE AS POSITIBE. THE BOTTLE HAD A YELLOW SENSOR UPON REMOVAL, INDICATIVE OF A POSITIVE BOTTLE. THE "NEGATIVE" RESULT WAS NOT GIVEN TO THE DOCTOR. RATHETER, THE SUBCULTURE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PT HAD MULTIPLE MYELOMA AND IS NOW DECEASED. THE FALSE BACT SA RESULT IS NOT KNOWN TO HAVE HAD ANY INFLUENCE ON THE TREATMENT OF THE PT. THE HOSP WHICH WAS PERFORMING THE BLOOD CULTURE AND USING THE BACT SA WAS NOT THE HOSP THAT WAS TREATING THE PT. IT IS UNK WHAT MEDICATIONS THE PT WAS ON AND WHAT THE CAUSE OF DEATH WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT SA MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death