BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 805739 · Received November 1, 2005

    Report

    Report Number
    2250051-2005-50505
    Event Type
    Other
    Date Received
    November 1, 2005
    Date of Event
    October 5, 2005
    Report Date
    November 1, 2005
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE/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 PIPETTOR JTC HAMILTON BONADUZ AG 7003009 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other