BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMEGROWN

    MDR report key: 1711484 · Received April 16, 2010

    Report

    Report Number
    MW5016165
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    September 22, 2008
    Report Date
    April 16, 2010
    Manufacturer
    HOMEGROWN
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TESTS OF BLOOD WERE ORDERED TO BE PERFORMED AND WERE PERFORMED IN THE EARLY MORNING HOURS. THE RESULTS WERE SENT ELECTRONICALLY TO THE COMPUTERIZED STORAGE SECTION ON THE RECORD. THE CRITICAL ABNORMALITY WAS IN THE INTERVAL CHANGE OVER THE 8 HOURS FROM THE EARLIER TEST, RATHER THAN THE ABSOLUTE RESULT OF THE TEST THAT WAS SILENTLY SENT TO THE ELECTRONIC REPOSITORY. NOT ONE HEALTH PROFESSIONAL KNEW IT WAS THERE UNTIL APPROX 6 HOURS LATER. THE NEW RESULT RETURNED SHOWING AN ABSOLUTE LEVEL LIFE THREATENING ANEMIA. THE CRITICAL TEST REFLECTING THE INTERVAL CHANGE WAS BURIED IN THE ELECTRONIC REPOSITORIES. THE PT DIED FROM BLOOD LOSS. THE ELECTRONIC DEVICE DID NOT WARN THERE WAS A NEW RESULT. THIS DEATH ASSOCIATED PROBLEM, THE FAILURE TO NOTIFY OF A NEW RESULT, IS A FLAW OF ALL ELECTRONIC REPOSITORIES OF PT'S RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEGROWN PHYSICIANS' PORTAL NSX HOMEGROWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death