BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 686975 · Received March 9, 2006

    Report

    Report Number
    2954730-2006-00094
    Event Type
    Malfunction
    Date Received
    March 9, 2006
    Date of Event
    February 8, 2006
    Report Date
    March 7, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CALLER ALLEGED RESULTS WHEN COMPARED WITH THE LAB AND ANOTHER POCD. THE FOLLOWING RESULTS WERE REPORTED: LAST WEEK IN NOV. INRATIO 4.7, LAB 3.4, 1/06 INRATIO 3.7, POCD 2.5, 1/06 INRATIO 5.3, LAB 3.6 (DOSE INCREASED), 1/06 INRATIO 5.7, POCD 4.1, 2/06 INRATIO 6.3, LAB 4.3, 2/06 INRATIO >7.5, 2/06 INRATIO 6.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050663

    Patients

    Seq Age Sex Outcome Treatment
    1 *