BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 618409 · Received June 14, 2005

    Report

    Report Number
    2250051-2004-02697
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 19, 2002
    Report Date
    July 29, 2004
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTL
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT FAILED TO ALERT THE OPERATOR THAT ASPIRATION OF THE WASH BUFFER WAS IMPAIRED DUE TO AN IMPROPERLY SEATED MICROWELL STRIP IN THE PLATE (MICROWELL STRIP HOLDER). NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR ELISA MICROWELL PLATE PROCESSOR JTL HAMILTON BONADUZ AG 7003015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other