BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK2

    MDR report key: 1617166 · Received February 22, 2010

    Report

    Report Number
    MW5014906
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 22, 2010
    Manufacturer
    BIOMERIUEX
    Product Code
    LTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VITEK 2 -BIOMERIEUX- MACHINE AT OUR INSTITUTION -(B) (6)- FAILED TO CORRECTLY IDENTIFY A (B) (6) ISOLATE AS BETA-LACTAM RESISTANT. IT REPORTED THE ISOLATE AS A (B) (6). WE ARE USING GP67 LOT # 132161040 CARDS ON THE VITEK 2 MACHINE. SPECIFICALLY, THE VITEK 2 MACHINE REPORTED THE OXACILLIN AS SENSITIVE AND THE CEFOXITIN AS SENSITIVE. THIS WAS CHECKED USING MANUAL METHOD CALLED KIRBY-BAUER -KB- OR DISK TESTING. BY KB THE CEFOXITIN WAS RESISTANT AND THE OXACILLIN WAS RESISTANT. FURTHERMORE, THIS PT'S ISOLATE CAME TO US INITIALLY FROM AN OUTSIDE HOSPITAL. THAT OUTSIDE HOSPITAL ALSO USED VITEK TO TEST THE SUSCEPTIBILITY OF THIS ISOLATE. THE OUTSIDE HOSP'S VITEK REPORTED, IT AS OXACILLIN RESISTANT AND CEFOXITIN SENSITIVE. WE ARE TESTING THIS ISOLATE WITH A MOLECULAR ASSAY TO DETECT A MECA CASSETTE AND WE ARE SENDING THE ISOLATE TO THE CDC FOR FURTHER CHARACTERIZATION. BECAUSE OF THIS SERIOUS DISCREPANCY, WE HAVE INSTITUTED MANUAL DISK TESTING, KB, FOR ALL (B) (6) ISOLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK2 VITEK LTW BIOMERIUEX VITEK 2- AST GP67 132161040

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other