BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1112015 · Received August 12, 2008

    Report

    Report Number
    2954730-2008-00498
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 7, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF REPEATED TEST USING INRATIO AT HOME AND DOCTOR'S OFFICE PROVIDED BY END-USER AT THE TIME THE COMPLAINT WAS FILED: BY THE USER TESTING 1.7, AT DOCTOR'S OFFICE 2.5, AVERAGE 2.1, SD 0.565685, %CV 26.945%. THE %CV IS GREATER THAN 20% AND CRITERIA IS NOT MET AS PER INTERNAL PROCEDURE, SO FUNCTIONAL TESTING WILL BE PERFORMED AS PART OF THE COMPLAINT INVESTIGATION. PRODUCT WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN REPEATED INRATION SELF TEST AND DOCTOR'S OFFICE TEST. THE DISCREPANT RESULTS ARE AS FOLLOWS: SELF TEST - 1.7, DOCTOR'S OFFICE = 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI