BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1832511 · Received September 13, 2010

    Report

    Report Number
    2250051-2010-00208
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 13, 2010
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THE TIP CLAMP IN POSITION #5 STUCK TO THE EJECTION SLEEVE. THE FSE REMOVED THE TIP CLAMP AND SLEEVE AND CLEANED IT. 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 SAMPLE 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