BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1002961 · Received February 11, 2008

    Report

    Report Number
    2250051-2008-80086
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    October 24, 2007
    Report Date
    February 11, 2008
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE THE ELISA MICROWELL PLATE WAS OUT OF POSITON CAUSING THE SUMMIT SAMPLE HANDLING SYSTEM TO DISPENSE SAMPLE/REAGENT INCORRECTLY MISSING THE MICROWELLS ALL TOGETHER OR DISPENSING SAMPLE/REAGENT INTO THE WRONG MICROWELLS ON AN ELISA MICROWELL PLATE. SAMPLE DELIVERED TO A MISALIGNED PLATE MAY RESULT IN AN ERRONEOUS RESULT NEGATIVE RESULT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTER JTC HAMILTON BONADUZ AG 7003009 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *