BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 719879 · Received May 19, 2006

    Report

    Report Number
    2954730-2006-00297
    Event Type
    Malfunction
    Date Received
    May 19, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 16, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER ALLEGED INPRECISION TEST RESULTS WITH INRATIO. REPORTED RESULTS AS FOLLOWS: LOT#050678, INR = 2.3, INR = 2.9 WITHIN 5 MIN WITH 2ND FS, LOT#060019, INR = 3.7 WITHIN 5 MIN WITH 3RD FS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050678

    Patients

    Seq Age Sex Outcome Treatment
    1 *