BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 692264 · Received March 22, 2006

    Report

    Report Number
    2954730-2006-00113
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    February 21, 2006
    Report Date
    March 21, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CALLER DISCREPANT RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED. 02/17/2006 INRATIO-1.7, LAB 2.3. 02/20/2006 INRATIO 5.7, LAB 3.0. TBD INRATIO-6.5, 4.0

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE, INC. * 050502

    Patients

    Seq Age Sex Outcome Treatment
    1 *