BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK STANDARD 45 SUSCEPTIBILITY CARD, GPS-107

    MDR report key: 555097 · Received April 28, 2004

    Report

    Report Number
    1950204-2004-00005
    Event Type
    Malfunction
    Date Received
    April 28, 2004
    Date of Event
    February 2, 2004
    Report Date
    April 27, 2004
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    Removal / Correction Number
    1950204-04/27/04-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A SMALL PERCENTAGE OF CARDS FROM VITEK GPS-107 LOT P108X WERE ERRONEOUSLY BAR CODED WHICH MAY CAUSE THE VITEK SYSTEM TO READ AND REPORT THESE CARDS AS VITEK GNS-133 OR VITEK GNS-794 CARDS INSTEAD OF GPS-107 CARDS. AS A RESULT OF THE DIFFERENT CONFIGURATIONS AND CONTENTS FOR THE TWO VITEK CARD TYPES THE FOLLOWING ANTIBIOTIC/TESTS WILL BE ERRONEOUSLY ANALYZED AND POTENTIALLY REPORTED IF A GPS-107 CARD IS READ AS A GNS-133 0R GNS-794 CARD: AMOXICILLIN/CLAVULANIC ACID, AMPICILLIN/SULBACTAM, CEFAZOLIN, CIPROFLOXACIN, CLINDAMYCIN, ERYTHROMYCIN, GENTAMICIN, GENTAMICIN 500, LEVOFLOXACIN, NITROFURATOIN, OXACILIN, PENICILIN G, RIFAMPIN, STREPTOMYCIN 2000, TETRACYCLINE, TRIMETH/SULFA, VANCOMYCIN, AND B-LACTAMASE. THIS MAY CAUSE FALSE SUSCEPTIBLE AND/OR FALSE RESISTANT RESULTS TO BE REPORTED IF THE ERROR IS NOT CAUGHT WHEN THE LAB REVIEWS THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK STANDARD 45 SUSCEPTIBILITY CARD, GPS-107 21CFR 866.165 FULLY AUTOMATED SHORT-TERM INCUBATION CYCLE AU LON BIOMERIEUX, INC. NA P108X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA