BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC EMR

    MDR report key: 14043665 · Received April 6, 2022

    Report

    Report Number
    MW5108816
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 4, 2022
    Manufacturer
    EPIC SYSTEMS CORP.
    Product Code
    MMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ORDER PLACED IN EPIC SOFTWARE, BUT LAB COULD NOT SEE IT, NO ORDER RESULTED. CSF COULD NOT BE DONE AS TOO MUCH TIME ELAPSED. OTHER LABS WERE DUBIOUS. RESULTED IN PROLONGED HOSPITALIZATION, EXPOSURE TO LONGER ABX, CONFUSION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013055 EPIC EMR BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH EPIC SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Hospitalization