BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1399932 · Received March 29, 2009

    Report

    Report Number
    2250051-2009-00175
    Event Type
    Malfunction
    Date Received
    March 29, 2009
    Date of Event
    May 27, 2009
    Report Date
    May 29, 2009
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND CLEANED THE PLUNGER CLAMP AND REPLACED THE TIP CLAMP IN POSITION D4. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT DID NOT PIPETTE REAGENT AND SAMPLE 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 PIPETTER JTC HAMILTON BONADUZ AG 7003009

    Patients

    Seq Age Sex Outcome Treatment
    1