Incorrect SAFETYREPORTID[C.1.1] and COMPANYNUMB[C.1.8.1] for cases with MedWatch and R2 initial reports

Summary

Incorrect SAFETYREPORTID[C.1.1] and COMPANYNUMB[C.1.8.1] in FAERS R3 Report in cases with both Medwatch and R2 initial reports (Bug 39613567).

Before

When an FAERS E2B(R3) report was generated for a case for the first time, and both MedWatch and E2B(R2) reports had previously been submitted to the FDA, the system incorrectly populated the SAFETYREPORTID[C.1.1] and COMPANYNUMB[C.1.8.1] elements with the Manufacturer Control Number (MCN) from an earlier MedWatch submission (Form 3500A or Form 14) instead of the SAFETYREPORTID[A.1.0.1] and COMPANYNUMB[A.1.10.1/ A.1.10.2] from the most recent E2B(R2) submission.

After

When an E2B(R2) report is submitted for a case report, the system uses the SAFETYREPORTID[A.1.0.1]and COMPANYNUMB[A.1.10.1/ A.1.10.2] generated by the R2 submission for all subsequent E2B(R3) reports. In this scenario, the Manufacturer Control Number (MCN) from the earlier MedWatch report is not reused. The MCN from Box G9, mapped to SAFETYREPORTID[C.1.1] and COMPANYNUMB[C.1.8.1], are used only when the initial submission was a paper MedWatch report and no electronic submission, such as an E2B(R2) report, exists.

Impacted module

E2B(R3) export (FAERS)