BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 754803 · Received November 8, 2005

    Report

    Report Number
    2954730-2005-00118
    Event Type
    Malfunction
    Date Received
    November 8, 2005
    Date of Event
    October 18, 2005
    Report Date
    November 3, 2005
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT METER EXHIBITED VARIATION IN TEST RESULTS WHEN COMPARED WITH ANOTHER POINT OF CARE METER AND THE LAB. THE FOLLOWING RESULTS WERE REPORTED: INRATIO, LAB, COAGUCHEK: 5.7, 3.6, 4.1. A STAFF MEMBER WAS ALSO TESTED USING TWO DIFFERENT STRIP LOTS. THE FOLLOWING RESULTS WERE REPORTED: LOT 050434 0.9, LOT 050473 0.8. CUSTOMER TO PERFORM ADDITIONAL COMPARISON TESTS USING BOTH STRIP LOTS FOLLOWED BY A LAB DRAW. 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. * 050434

    Patients

    Seq Age Sex Outcome Treatment
    1 *