BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2

    MDR report key: 716903 · Received May 2, 2006

    Report

    Report Number
    MW1038973
    Event Type
    Malfunction
    Date Received
    May 2, 2006
    Report Date
    May 2, 2006
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BASED ON THE RECENT STUDY IN THE MARCH JCM ON FALSE-SUSCEPTIBILITY ERROR RATES FOR P. AERUGINOSA WITH AUTOMATED INSTRUMENTS, WE HAVE TAKEN A LOOK AT OUR VITEK II RESULTS FOR PIPERACILLIN VS. P. AERUGINOSA, USING BK TESTING AS THE GOLD STANDARD. ONE HUNDRED ONE ISOLATES WERE TESTED; WE FOUND A 5% VERY MAJOR ERROR RATE. ALL OF THESE ERRORS WERE FOR ORGANISMS WITH PIPERACILLIN MICS OF 32 OR 64 -AS MEASURED BY VITEK-; IN THE GROUP OF 12 ISOLATES, 5 WERE FALSELY SUSCEPTIBLE. FOR ALL OTHER MICS, VITEK AND BK HAD ABSOLUTE AGREEMENT. THESE DATA WERE COLLECTED USING CARD #AST-GN09. LOT NUMBER 106028040, EXPIRES 09/20/07. THE VITEK 2 SOFTWARE IS VERSION 4.02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK 2 * JTN BIOMERIEUX, INC. VITEK 2 106028040

    Patients

    Seq Age Sex Outcome Treatment
    1 *