BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK SYSTEM

    MDR report key: 39706 · Received September 6, 1996

    Report

    Report Number
    1950204-1996-00001
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 6, 1996
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Product Code
    LTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ENTERED THE PRODUCT BAR CODE FOR A NEW ANTIBIOTIC SUSCEPTIBILITY TEST PANEL (GNS-102) PRIOR TO LOADING THE NEW VERSION OF SOFTWARE (VTK-R04.01) REQUIRED TO OBTAIN RESULTS FROM THAT NEW TEST PANEL. THE GNS-102 LABELING INCLUDED THE REQUIREMENT FOR LOADING THE VTK-R04.01 SOFTWARE FOR THIS TEST PANEL. THE NEW GNS-102 TEST PANEL CONTAINS A THREE WELL CONFIGURATION FOR OFLOXACIN SUSCEPTIBILITY. EARLIER VERSIONS OF SOFTWARE WERE ENCODED FOR THE PRIOR TWO WELL OFLOXACIN CONFIGURATION ONLY. WHEN THE GNS-102 PRODUCT BAR CODE IS ENTERED INTO THE COMPUTER PRIOR TO LOADING THE NEW VTK-R04.01 SOFTWARE, THE NEW OFLOXACIN CONFIGURATION IS NOT CORRECTLY RECOGNIZED AND RESULTS ARE NOT CORRECTLY REPORTED FOR OFLOXACIN AND SUBSEQUENT DRUGS ON THE TEST PANEL. NO RESULTS FOR THE NEW TEST PANEL CONFIGURATIONS ARE POSSIBLE UNTIL THE NEW SOFTWARE IS LOADED. IF THE TEST PANEL PRODUCT CODE IS CORRECTLY ENTERED AFTER LOADING THE VTK-R04.01 SOFTWARE, THE RESULTS ARE CORRECTLY REPORTED. THE ERROR CONDITION OCCURS ONLY IF THE NEW TEST PANEL BAR CODE IS ENTERED PRIOR TO LOADING THE NEW SOFTWARE, AND THE TEST PANEL IS USED FOR DETERMINATIONS WITHOUT RE-ENTERING THE TEST PANEL PRODUCT BAR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK SYSTEM ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEM LTT BIOMERIEUX VITEK, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other