10 Similar Device Case Processing (Single Entity Combination Products)

These are the steps for creating/processing cases with Non-US marketed devices that involve reportable malfunction and have similar devices marketed in the US as part of Single entity Combination Product:

1. Book-in a Case with information received as per Source documents.
2. If the Suspect Device had caused a reportable malfunction, then check for the Product Portfolio for Similar devices marketed in the US as Combination Product.
3. If such a product exists, then add the Product from the Product browser and enter the following data in the Drug tab:
   • Product type = Treatment / Other
   • Drug not administered = Ticked
4. In the Device tab, enter Similar Device = Ticked.
5. Select Combination Product in the General > Case Classification field.
6. Save the case and ensure that all mandatory data required for CDER submission is entered.
7. Perform Auto-scheduling and system schedules an E2B report to CDER agency using the profile selected in the reporting destination EDI tab.
8. Click the Draft link to preview the report in XML view.
   For E2B(R2), the <combinationproductreport> element is populated with value 1, indicating ICSR contains combination product.

   For E2B(R3), the <combinationproductreport> element is populated as True.

   Note:

   You can generate either E2B(R2) or E2B(R3) report.

   For E2B(R2), the <drugcharacterization> element is populated with value 5, indicating Similar Device.

   For E2B(R3), the <otherdrugcharacterization> element is populated with value 1, indicating Similar Device.

The Similar Device data is populated in ICSR.