BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 673634 · Received February 6, 2006

    Report

    Report Number
    2954730-2006-00034
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    December 21, 2005
    Report Date
    February 3, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS, WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED: 12/15/2005, INRATIO: 1.9, 12/18/05, INTRA: 1.8, LAB: 5.5, 12/19/05, INRATIO: 1.8, 12/20/05, INRATIO: 1.3, LAB: 3.1 1/25/06, INRATIO: 1.3, LAB: 3.2. A REPLACEMENT METER SHALL BE SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *