BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 975065 · Received July 20, 2007

    Report

    Report Number
    2250051-2007-00372
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JTC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE COLLOT AND LDD SPRING IN THE PROBLEM AREA OF THE PIPETTER ASSEMBLY. THE INSTRUMENT WAS INSPECTED, TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *