How is MIR reporting handled for Non-serious Reportable Incidents?

The out-of-the-box MIR Profile requires at least one Serious related event to populate the Incident Start and End Dates. In order to achieve reporting of Non-Serious Reportable Incidents, the following is recommended:

  • Addition of a User Defined Field in the Event Tab to indicate if the Event is a Reportable Malfunction (Yes/No). This field would indicate that the Event was not serious. However it would be a Reportable Malfunction.
  • Configuration of Health Impact Coding with IMDRF Code F26 Indicating that there was no Health Impact. This ensures the Incident Classification in the MIR Report would be Other Reportable Incidents.
  • Customization of Message Profile, by updating the SQL for Admin_info block.
  • Reporting Rules configured to schedule MIR Report based on the UDF added.