BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 673637 · Received February 6, 2006

    Report

    Report Number
    2954730-2006-00046
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    January 9, 2006
    Report Date
    February 3, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: INRATIO: 1.5, LAB: 2.3, INRATIO: 0.7, LAB: 2.2.

    Description of Event or Problem · 1

    IN 2006, FURTHER TESTING WAS PERFORMED TO COMPARE THE OLD STRIP LOT WITH THE NEW STRIP LOT. THE FOLLOWING INRATIO RESULTS WERE REPORTED. OLD LOT -2.6. NEW LOT (050664) - 1.1. A DIFFERENT PT WAS TESTED. RESULTS ARE AS FOLLOWS: OLD LOT -2.1, NEW LOT -2.1. FURTHER TESTING WAS PERFORMED AND A LAB DRAW WAS ADDED. THE RESULTS ARE AS FOLLOWS: OLD LOT -2.5, NEW LOT -2.3, LAB -2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GIS HEMOSENSE, INC. * 050664

    Patients

    Seq Age Sex Outcome Treatment
    1 *