BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 697090 · Received September 30, 2005

    Report

    Report Number
    2954730-2005-00069
    Event Type
    Malfunction
    Date Received
    September 30, 2005
    Date of Event
    August 25, 2005
    Report Date
    September 30, 2005
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT DEVICE EXHIBITED VARIATION IN TEST RESULTS WHEN COMPARED WITH ANOTHER POC METER. THE FOLLOWING RESULTS WERE REPORTED. INRATIO:3.7,3.7,3.7,4.6(NEW STRIP OF 050387), 4.6. PROTIME: 2.8,2.7,3.1. PT WILL CONSULT WITH HER PHYSICIAN AS TO WHETHER TO CONTINUE TESTING USING INRATIO. FURTHER FOLLOW UP TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TEST TIME JPA HEMOSENSE, INC. * 050154

    Patients

    Seq Age Sex Outcome Treatment
    1 *