BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1210885 · Received July 30, 2008

    Report

    Report Number
    2250051-2008-00389
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JTC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SVC ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED PLUNGER CLAMP POSITION #2. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * JTC ORTHO-CLINICAL DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1