Common Considerations for Coding Information

Consider the following points to add or update the coding information for Medical Device Problem, Health Impact, Clinical Signs, and Evaluation/Investigation:

• Medical Device, Patient Problem codes and Evaluation codes were part of the Product > Device > MW Info tab, are moved to Product > Device > Patient Problem and Device Problem Information starting Oracle Argus Safety 8.2.2 release. The Patient Problem codes are retained in the Product > Device tab to view any legacy data if present, but data entry is longer allowed.
• Device Coding is done only by invoking the look-up that displays both the FDA and IMDRF codes for Medical Device Problem Coding and Evaluation/Investigation Coding. Only the IMDRF codes are displayed in Health Impact Coding, Clinical Sign Coding, and Device Component Coding.
• The decode values are not displayed for obsolete codes. Coding User/Data Entry User is expected to recode such data against the latest IMDRF repository.
• If an appropriate or feasible code is not found to describe any of the Annex A–G, then it is recommended to explain the reason why the current terms or codes are not appropriate by using the free text field provided on the relevant Coding window. Select the check box labelled If you think the incident is unique and a suitable IMDRF term is missing, briefly explain and provide a clear explanation.

Following are the default Annex codes provided by the European commission in their regulations.

Annexures	Default IMDRF code
Annex- A	A27
Annex -E	E2402
Annex-F	F28
Annex-D	D17
Annex-G	G07002