BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 717795 · Received May 16, 2006

    Report

    Report Number
    2954730-2006-00285
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    February 22, 2006
    Report Date
    May 13, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IMPRECISION RESULTS WITH INRATIO RESULTS AS FOLLOWS: INRATIO PRECISION DATA PROVIDED BY END-USER LOT 050595; 2006, FIRST TEST INR = 4.7, SECOND TEST INR = 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050595

    Patients

    Seq Age Sex Outcome Treatment
    1 *