BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 705910 · Received April 26, 2006

    Report

    Report Number
    2954730-2006-00232
    Event Type
    Injury
    Date Received
    April 26, 2006
    Date of Event
    April 5, 2006
    Report Date
    April 24, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISCREPANT RESULTS WHEN COMPARED WITH THE LAB. REPORTED RESULTS ARE AS FOLLOWS: DATE 04/2006, INRATIO 2.1,7.5, LAB 10,10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R