BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT MONITORING SYSTEM

    MDR report key: 1031943 · Received April 3, 2008

    Report

    Report Number
    1031943
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    February 27, 2008
    Report Date
    April 3, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF DVT X2, HYPERCOAGULABLE STATE, AND CHRONIC TREATMENT WITH COUMADIN. PATIENT WAS SEEN IN COUMADIN CLINIC WHERE PATIENT WAS TESTED THREE TIMES. FIRST TIME THE MACHINE READ "ERROR". TEST WAS REPEATED TWO MORE TIMES WITH RESULT OF INR 2.2 AND 2.3. PATIENT WENT TO A SECOND FACILITY FOR A CT SCAN FOR AN UNRELATED ISSUE. CT RESULTS DEMONSTRATED ACUTE HEMORRHAGE WITH THE RIGHT INTRARENAL COLLECTING SYSTEM. PATIENT WENT TO EMERGENCY DEPARTMENT WITH COMPLAINT, AND INR RESULT VIA VENOUS DRAW WAS 10.8. PATIENT WAS TREATED WITH VITAMIN K AND FRESH FROZEN PLASMA. PATIENT WAS DISCHARGED WITH AN INR OF 2, AND ON COUMADIN 5 MG. PATIENT'S PRIOR COUMADIN DOSE WAS 40 MG AND HAD BEEN INCREASED TO 90 MG BASED ON RESULTS OBTAINED FROM HEMOSENSE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PT MONITORING SYSTEM ANALYZER, INR JPA HEMOSENSE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention