BEUDAMED
    FDA Adverse Event Summary report: N

    EPIC MEDICAL SOFTWARE

    MDR report key: 8202922 · Received December 27, 2018

    Report

    Report Number
    MW5082659
    Date Received
    December 27, 2018
    Report Date
    December 27, 2018
    Manufacturer
    EPIC SYSTEMS CORPORATION
    Product Code
    OUG
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED INTO THE HOSPITAL AND THEIR HOME MEDICATIONS WERE DOCUMENTED. PATIENT¿S HOME MEDICATIONS INCLUDED RYTHMOL EXTENDED RELEASE 225MG BY MOUTH TWICE DAILY. RYTHMOL EXTENDED RELEASE VERSUS IMMEDIATE RELEASE IS NOT DISTINGUISHED WITHIN EPIC. WHILE RECONCILING MEDICATIONS, RYTHMOL IMMEDIATE RELEASE 225MG BY MOUTH TWICE DAILY WAS ORDERED AND GIVEN TO THE PATIENT INSTEAD OF RYTHMOL EXTENDED RELEASE 225MG BY MOUTH TWICE DAILY. THIS ERROR LEAD TO THE PATIENT BEING UNDER DOSED DURING THEIR HOSPITAL STAY. PATIENT WAS DISCHARGED BACK ON RYTHMOL EXTENDED RELEASE 225MG BY MOUTH TWICE DAILY. IN DOING RESEARCH, WE NOTED THERE WAS AN ISMP REPORT INVOLVING THE SAME ISSUE WITH OXYCODONE EXTENDED RELEASE VERSUS IMMEDIATE RELEASE. WE THINK THERE SHOULD BE A COMPREHENSIVE REVIEW INVOLVING ALL PRODUCTS WITH THE DIFFERENT FORMULATIONS. (B)(6); ACCESS NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040579 EPIC MEDICAL SOFTWARE MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1