BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1020777 · Received March 18, 2008

    Report

    Report Number
    2250051-2008-00187
    Event Type
    Malfunction
    Date Received
    March 18, 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 DEFECTIVE PLUNGER CLAMP IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED PLUNGER CLAMP # 6 AND VERIFIED HOLD AND PULL FORCE ON ALL TIPS. 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