BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1650136 · Received April 5, 2010

    Report

    Report Number
    2250051-2010-00085
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 5, 2010
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND PLUNGER CLAMP EJECT PIN #12 STUCK. THE FSE CLEANED THE PLUNGER CLAMP AND EXERCISED THE EJECT SPRING. THE FSE PERFORMED SPLLD CHECKING PROCEDURE AND TESTED SUMMIT WITH OAS USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    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.THE REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTER JTC HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1