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Value of TYPEOFREPORTABLEEVENT(H1) Must Be Present For eMDRs Submitted by Manufacturers (Doc ID 2938131.1)

Last updated on JANUARY 03, 2025

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.

Symptoms

 

The following error appears when viewing initial (Importer/Distributor) eMDR from the case which has non-serious event only.


Errors:

     General error while creating ICSR report.
     The value of TYPEOFREPORTABLEEVENT(H1) must be present for eMDRs submitted by Manufacturers

Steps:

  1. Go to Argus Console > Codelist > reporting destination
  2. View the settings for eMDR
  3. In the "Agency Information" tab, Importer and/or Distributor is ticked in Contact Type section


  4. Create a new case with device license
  5. Confirm that all the flags in the Seriousness Criteria are un-checked for all the events
  6. Schedule initial eMDR for the reporting destination that you confirmed at step1-3
  7. Save the case
  8. Click the draft link

     

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution

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