Guide to Completing Device Incident Reports for the TGA

1. General Advice for Submitting Reports

Always review your report thoroughly before submission to ensure all mandatory fields are completed, along with as many optional sections as possible, and that the information is accurate, appropriate, and logical. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

If no Device Incident Report (DIR) number is received after submission, do not resubmit, as this may create duplicates. Instead, email iris@health.gov.au to obtain the DIR number and report any system issues. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Reports are only accepted via the official TGA adverse event reporting form. Incorrectly filled reports are returned to the reporter. You may attach your company's internal form after populating the TGA form correctly. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

The TGA detects and merges duplicates into a single DIR number. If you identify a duplicate, email iris@health.gov.au with details. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Use Ctrl+C and Ctrl+V for cut-and-paste operations when entering information into the IRIS system. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Keep your TGA client details account up to date, as only listed contacts receive confidential communications from TGA investigators. Use a standardised or central email address for sponsors to avoid loss of information due to staff changes. Notify iris@health.gov.au of changes in regulatory affairs officers. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

For enquiries about reports, contact iris@health.gov.au or call 1800 809 361. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

2. Device ARTG Number

Enter only one ARTG entry per field, corresponding to the 'main/primary' device identified in the clinical event description. If unsure which is primary, submit separate reports for each device involved. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

List other involved devices in the 'Other devices involved' section, including ARTG numbers if known. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

The TGA verifies the ARTG number and device description against the clinical event; corrections may be made or clarification requested. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

After submission, ARTG details from the TBS portal are used for internal lookup, auto-populating fields like GMDN term and manufacturer (with possible delay). In the MDIR system, sponsors view the selected ARTG, and entered details may temporarily appear removed—this is normal. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

The TGA cannot identify devices from catalogue number alone; include model number to help identify brand name for searches on DAEN, ARTG, and IRIS. For orthopaedic devices in the AOANJRR database, catalogue numbers may be used, but model number/description is still recommended. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

3. Device Description

Provide details to clearly identify the device, such as brand name, model, serial number, lot number, kind/type of device, or software version. Always include the brand/trade name in reports. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Avoid capital letters or abbreviations in descriptions. This information appears publicly on the Database of Adverse Event Notifications (DAEN) and must be clear and accurate. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

4. Clinical Event Information

Describe the event only in this section; do not include patient outcome or device/event analysis (use dedicated sections for those). Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

This section appears on DAEN, so ensure the description is adequate and accurate. The TGA removes disclaimers and non-clinical information from here, relocating it elsewhere in the database, and may add relevant details if needed. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

5. Similar Events

Base similarity on the clinical event description, not the cause. Report the number of similar events known to the sponsor/manufacturer, along with rates for Australia and worldwide. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Rates support incident trending analysis to detect emerging issues. Provide data preferably over three years (current year of event, one year prior, two years prior), ideally as incidence rate or percentage (number of similar events / total supplied or sold × 100). Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Examples include:

• Australia: 12 similar events from 3,187 units sold in 2018 (0.37%).
• Worldwide: 235 similar events from 68,078 units sold in 2018 (0.34%). Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Provide current rates even if events are not deemed device-related (for baseline comparison); note any company concerns about causality in the rate section. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

6. Questionnaires and Follow-up

After submission and risk assessment, an investigator may be assigned. If information is conflicting, inadequate, or needs clarification, a questionnaire or further communication is sent. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report

Most questionnaires arise from reports by healthcare professionals or consumers that lack device/incident analysis, requiring sponsor input to confirm if the event is isolated, low-frequency, low-risk, or if the manufacturer is addressing the root cause. Source: https://www.tga.gov.au/resources/resources/user-guide/frequently-asked-questions-about-filling-device-incident-report