BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 1625970 · Received March 10, 2010

    Report

    Report Number
    2250051-2010-00055
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 10, 2010
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) FOUND A BAD PLUNGER CLAMP. THE FSE REPLACED THE PLUNGER CLAMP AND LLD SPRING. 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 DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE AND REAGENT 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTER JTC 7003009

    Patients

    Seq Age Sex Outcome Treatment
    1