BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1020783 · Received March 17, 2008

    Report

    Report Number
    2250051-2008-00193
    Event Type
    Malfunction
    Date Received
    March 17, 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 THE PLUNGER AND TIP CLAMPS IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE INSTRUMENT WAS INSPECTED, TESTED WITHOUT FURTHER PROBLEM AND 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