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.
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
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