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eMDR Follow-Up Report was Rejected Due to Having Follow-up Number TWICE in the Report (Doc ID 2894479.1)

Last updated on DECEMBER 01, 2022

Applies to:

Oracle Argus Safety Japan - Version 8.2 and later
Oracle Argus Interchange - Version 8.2 and later
Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.

Symptoms

eMDR Follow-Up Report was Rejected by FDA due to having <!--G6: Follow-up Number--> element TWICE in the report

Steps to Repeat:
1. Create a reportable Device Case
2. Schedule an initial eMDR report to FDA reporting destination
3. Lock the case, Generate the report and mark it as submitted
4. Unlock the case, add a significant f/u
5. Schedule a f/u eMDR report to FDA reporting destination
6. Generate the Report
7. Observe that the <!--G6: Follow-up Number--> is present twice in the report 

Cause

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In this Document
Symptoms
Cause
Solution
References

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