BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 588688 · Received June 28, 2004

    Report

    Report Number
    2250051-2004-02649
    Event Type
    Other
    Date Received
    June 28, 2004
    Date of Event
    May 28, 2004
    Report Date
    June 28, 2004
    Manufacturer
    HAMIGON BONADUZ AG
    Product Code
    JTC
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT GENERATED A DIS402 DISPENSER DRIVE STEP LOST ERROR DURING A PARTIAL PLATE RUN. THE SAMPLE HANDLING SOFTWARE THE USER WAS USING DID NOT GENERATE AN ALARM TO THE USER. THE ERROR WAS CAPTURED IN THE ORTHO SUMMIT PROCESSOR ERROR LOG. 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 JTC HAMIGON BONADUZ AG 7003015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other