BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC

    MDR report key: 846169 · Received April 27, 2007

    Report

    Report Number
    846169
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Report Date
    April 27, 2007
    Manufacturer
    EPIC SYSTEMS CORPORATION
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A KNOWN ALLERGY TO TYLENOL WHICH HAD BEEN ENTERED INTO THE SYSTEM LAST YEAR. WE CANNOT SHOW THAT THE PHARMACIST ENTERING THE MEDICATION OR THE NURSE DOCUMENTING THE MEDICATION GOT AN ALERT TO SAY THE PATIENT WAS ALLERGIC TO THE MEDICATION, AS THEY SHOULD HAVE. THE TYLENOL WAS DISPENSED TO THE PATIENT BY THE NURSE. THE PATIENT HAD A HISTORY OF GETTING HIVES WITH THE MEDICATION. SHE WAS GIVEN BENADRYL ONCE THE ALLERGY WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC HEALTH INFORMATION SYSTEM LNX EPIC SYSTEMS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR