BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. PT CUVETTE

    MDR report key: 2423070 · Received January 17, 2012

    Report

    Report Number
    2423070
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    February 15, 2011
    Report Date
    October 5, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL TECHNIDYNE, CORP (ITC) CUVETTE WAS USED FOR POINT-OF-CARE TESTING OF INR. THE LOT USED MAY HAVE REPORTED A HIGHER THAN ACTUAL RESULT. THE CUVETTE WAS RECALLED BY ITC. A PATIENT WAS ADMITTED WITH CEREBROVASCULAR ACCIDENT (CVA) AND CENTRAL NERVOUS SYSTEM (CNS) VASCULITIS WITH A INR RESULT OF 1.7. A SUBSEQUENT INR RESULT WAS 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. PT CUVETTE HEMOCHRON JR. PT CUVETTE J201 GJS INTERNATIONAL TECHNIDYNE CORP. * M0JPT079

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR