BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3031122 · Received July 14, 2006

    Report

    Report Number
    2954730-2006-00400
    Event Type
    Injury
    Date Received
    July 14, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 12, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2006, INRATIO: 2.3, LAB: 1.6. CALLER ADMITTED TO EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE, INC. 050749

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization