BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PLUS

    MDR report key: 1210983 · Received July 1, 2008

    Report

    Report Number
    2250051-2008-80339
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 30, 2008
    Report Date
    July 1, 2008
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PLUS (MICROLAB AT PLUS 2) INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE/REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PLUS SAMPLE PIPETTER JTC HAMILTON BONADUZ AG 1120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *