BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1127863 · Received June 26, 2008

    Report

    Report Number
    2250051-2008-80285
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 26, 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 ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    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 *