BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1121863 · Received June 12, 2008

    Report

    Report Number
    2250051-2008-00278
    Event Type
    Malfunction
    Date Received
    June 12, 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 FOUND A DAMAGED COLLECT IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED PLUNGER CLAMP, TIP CLAMP, TIP CLAMP SLEEVE AND COMPRESSION SPRING TO CORRECT THE PROBLEM. THE INSTRUMENT WAS CLEANED, 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