BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

    MDR report key: 655758 · Received December 16, 2005

    Report

    Report Number
    3002769706-2005-00035
    Event Type
    Death
    Date Received
    December 16, 2005
    Date of Event
    November 20, 2005
    Report Date
    December 13, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED CO IN 2005 FOR ASSISTANCE IN CLEARING A STRING SPACE FORMAT ERROR ON THEIR BACT/VIEW SOFTWARE. WHEN A STRING SPACE FORMAT ERROR OCCURS, THE BACT/VIEW COMPUTER WILL STOP COMMUNICATING WITH A LIS SYSTEM UNTIL THE ERROR IS CLEARED. THE CUSTOMER INFORMED CO DURING THIS CALL OF A POSITIVE BACT/ALERT BOTTLE RESULT THAT WAS NOT TRANSMITTED TO THEIR LIS DURING THE TIME BEFORE THE ERROR MESSAGE WAS CLEARED. THE LAB WAS NOT STAFFED ON SUNDAY, AND THEY HAD TURNED OFF THEIR SYSTEM'S AUDIBLE ALARMS. THEY DID NOT REALIZE THAT A BOTTLE HAD GONE POSITIVE, AND THAT THE BACT/VIEW COMPUTER WAS NO LONGER COMMUNICATING WITH THEIR LIS SYSTEM UNTIL LATE MORNING OF THE SAME DAY. THE CUSTOMER CALLED CO BACK THE NEXT DAY IN THE EVENING TO INFORM CO THAT THE PT WHO RECEIVED THE CONTAMINATED PLATELETS HAD DIED. THE BLOOD BANK DETERMINED THAT THE PLATELETS WERE CONTAMINATED WITH E-COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT 3D MICROBIAL DETECTION SYSTEM MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 210147 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death