BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 846584 · Received December 17, 2004

    Report

    Report Number
    2250051-2004-02910
    Event Type
    Other
    Date Received
    December 17, 2004
    Date of Event
    November 18, 2004
    Report Date
    December 17, 2004
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE/REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THE 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 7003008 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other