Case Form changes

New fields have been added to capture additional device-related data to support MIR reporting:

• Product > Device
• Product > Device > EU/CA Device

To help you perform coding using FDA codes and IMDRF codes at the same time, the Patient Problem and Device Problem Information and Evaluation / Investigation Code Information sections in the M/W Info dialog box have been moved to Product > Device.

IMDRF codes fields have been added to the Patient Problem and Device Problem Information and Evaluation / Investigation Code Information sections. The lookup dialog boxes in these sections now display the FDA codes along with IMDRF codes.

A new button under the Device tab allows you to access similar incidents:

• Product > Device tab > Similar Incidents

The Similar Incidents dialog box allows you to capture details of the similar incidents required to be submitted as part of the MIR Report. The identification and computation of count of similar incidents is performed outside the Oracle Argus system, and fields to capture the results are provided in the Similar Incidents dialog box.