BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 673618 · Received February 6, 2006

    Report

    Report Number
    2954730-2006-00023
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    November 29, 2005
    Report Date
    February 1, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS, WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED: 11/2005, INRATIO: 2.7, LAB: 5.5. PT WAS ADMINISTERED VITAMIN K TO PREVENT SERIOUS INJURY. THE NEXT DAY, INRATIO: 2.0, LAB: 7.8, A NEW STRIP LOT (050515) WAS SENT TO THE CUSTOMER FOR COMPARISON TESTING AGAINST THE LAB. THE FOLLOWING RESULTS WERE REPORTED: 12/2005, INRATIO: 6.1, LAB: 6.8, INRATIO 1.2 (RETESTING USING LOT 050487).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GIS HEMOSENSE, INC. * 050487

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention