BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSCRIPTS PRO EHR

    MDR report key: 2140502 · Received June 21, 2011

    Report

    Report Number
    MW5021097
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ALLSCRIPTS SOLUTIONS
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON VALIDATION OF ALLSCRIPTS PRO EHR VERSION 9.2, IT WAS FOUND THAT ONCE LAB RESULTS ARE AMENDED, THE ORIGINAL REPORTED LAB RESULT IS NO LONGER RETRIEVABLE IN THE SYSTEM/CHART. THIS WORKED PROPERLY IN EARLIER VERSIONS AND WAS PROMPTLY REPORTED TO ALLSCRIPTS CLIENT SUPPORT. ALLSCRIPTS HAS NOT CORRECTED THE PROBLEM AFTER SEVERAL ATTEMPTS TO REPORT THE PROBLEM AND OBTAIN CORRECTIVE ACTION DOCUMENTATION. NOTHING HAS BEEN PROVIDED BY ALLSCRIPTS AS A REMEDY TO THIS PROBLEM. FOR LABORATORY COMPLIANCE, ORIGINALLY REPORTED LAB RESULTS MUST REMAIN RETRIEVABLE AND IT MUST BE CLEAR THE RESULT HAS BEEN AMENDED. WE ARE UNABLE TO COMPLY WITH THIS AS LONG AS ALLSCRIPTS PRO EHR VERSION 9.2 IS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLSCRIPTS PRO EHR NONE JQP ALLSCRIPTS SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1