BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR PT CUVETTE

    MDR report key: 2212802 · Received August 12, 2011

    Report

    Report Number
    2212802
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ITC
    Product Code
    GFO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ITC (INTERNATIONAL TECHDYNE CORPORATION) CUVETTE WAS USED FOR POINT OF CARE TESTING OF INR (INTERNATIONAL NORMAL RATIO). THE LOT USED FOR TESTING MAY HAVE REPORTED HIGHER THAN ACTUAL RESULTS AND RESULTED IN ADMINISTERING A LOW DOSE OF MEDICATION TO THE PATIENT. THE CUVETTES WERE RECALLED BY ITC. THE PATIENT WAS ADMITTED WITH CVA (CARDIOVASCULAR ACCIDENT).======================MANUFACTURER RESPONSE FOR HEMOCHRON JR. PT CUVETTE J201, HEMOCHRON JR PT CUVETTE (PER SITE REPORTER)======================ITC HAS A CLINICAL ESCALATION TEAM WHICH IS REVIEWING THE CASES THOUGHT TO BE RELATED TO THE INR RESULTS.======================MANUFACTURER RESPONSE FOR HEMOCHRON JR. PT CUVETTE J201, HEMOCHRON JR PT CUVETTE (PER SITE REPORTER)======================ITC HAS A CLINICAL ESCALATION TEAM WHICH IS REVIEWING THE CASES THOUGHT TO BE RELATED TO THE INR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR PT CUVETTE HEMOCHRON JR. PT CUVETTE J201 GFO ITC UNK M0JPT079

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR