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Inclusion in Argus Safety Versions 7.x and 8.0 of MDR Adverse Event Codes as per Updates Made to the FDA's Coding Resource Page (Doc ID 2415658.1)

Last updated on AUGUST 13, 2018

Applies to:

Oracle Argus Safety - Version 7.0.0 to 8.0 [Release 7.0.0 to 8.0]
Information in this document applies to any platform.
13-Aug-2018: instructions for testing the workaround modified to include UI changes in 7x and 80x.

Goal

The Center for Devices and Radiological Health (CDRH) published the list of FDA Adverse Event codes to be used in section F10 (Event Problem Codes) and section H6 (Event Problem and Evaluation Codes) of the MedWatch Device report in order to be harmonized with the IMDRF Adverse Event Reporting Terminologies.

The FDA Coding Resource page has details on updates to FDA Adverse Event Codes.
This is the link to the current and future MDR Adverse Event Codes
The list contains new codes and inactive codes that are effective from July 2018.

This document provides a solution for inserting new codes into the Argus factory data for Device, Patient and Evaluation codes (CFG_MEDWATCH_CODES table) until they are provided as a part of the standard Argus product offering; this is logged as enhancement request 27577310 - eMDR:Update the device problem codes used for F10, H6 as per DPC hierarchy which will be implemented in Argus 8.2. 

The solution does not provide the following:

  • Scripts are not provided to update the Term description or Definition for the existing records as only the codes are used in the Medwatch Device reports
  • Scripts are not provided to mark a term as inactive in CFG_MEDWATCH_CODES, the current table structure does not have this capability. The inactive codes could be renamed with a prefix or suffix to indicate that they are inactive

 

 

Solution

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