BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR PT CUVETTE

    MDR report key: 2212801 · Received August 12, 2011

    Report

    Report Number
    2212801
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    January 17, 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. THE LOT NUMBER USED GAVE AN INR OF 2.5 WHICH MAY HAVE REPORTED HIGHER THAN ACTUAL RESULT. THE INR ON AT A LATER DAY WAS 1.5. THE CUVETTE WAS RECALLED BY ITC.======================MANUFACTURER RESPONSE FOR HEMOCHRON JR. PT CUVETTE J201, HEMOCHRON JR PT CUVETTE (PER SITE REPORTER)======================A CLINICAL ESCALATION TEAM HAS BEEN CREATED TO REVIEW EACH CASE.======================MANUFACTURER RESPONSE FOR HEMOCHRON JR. PT CUVETTE J201, HEMOCHRON JR PT CUVETTE (PER SITE REPORTER)======================A CLINICAL ESCALATION TEAM HAS BEEN CREATED TO REVIEW EACH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR PT CUVETTE HEMOCHRON JR. PT CUVETTE J201 GFO ITC * G0JPT075

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR