BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRONIC MEDICAL RECORD

    MDR report key: 5495524 · Received March 8, 2016

    Report

    Report Number
    MW5060847
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    March 6, 2016
    Report Date
    March 8, 2016
    Manufacturer
    EPIC
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE WAS A DEEP VEIN THROMBOSIS AFFLICTING THIS PT, FOR WHICH HE WAS BEING TREATED WITH COUMADIN. AN INR WAS DEPOSITED INTO THE ELECTRONIC CARE RECORD DEVICE WITHOUT NOTICE OR WARNING. IT WAS ELEVATED AND REQUIRED THAT COUMADIN NOT BE ADMINISTERED, BUT, NO ONE SAW THE RESULT THAT WAS SILENT IN THE COAG SILO. CONSEQUENTLY, THE USUAL DOSE OF COUMADIN WAS ADMINISTERED THAT RESULTED IN AN TNR THAT WAS MARKEDLY ELEVATED, THAT REQUIRED IMMEDIATE REVERSAL. THERE WAS A 5 GRAM DECREASED IN HEMOGLOBIN THAT THREATENED THE LIFE AND WELL BEING OF THIS PT. IT IS A WIDESPREAD PROBLEM IN EHR DRIVEN CARE THAT DISEASE CRITICAL RESULTS COME BACK SILENTLY, AND SOMETIMES SUCH IS DEADLY. OVERSIGHT AND CORRECTION OF THIS DEFECT IS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144272 ELECTRONIC MEDICAL RECORD MDDS/EHR NSX EPIC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R