BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 880836 · Received June 28, 2007

    Report

    Report Number
    2250051-2007-70336
    Event Type
    Malfunction
    Date Received
    June 28, 2007
    Date of Event
    May 11, 2007
    Report Date
    June 28, 2007
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE BARCODE SCANNER ON THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT MISREAD THE BARCODE IN MULTIPLE WELL POSITIONS. A BARCODE MISREAD COULD RESULT IN A SAMPLE FROM ONE PT BEING MISINTERPRETED FOR ANOTHER. 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 *