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If you are unsure of what is required once you have read this document please email iris@health.gov.au with your queries.
Important information
Please read your report thoroughly before submitting to the TGA to ensure you have provided information in all of the mandatory fields, as well as all possible sections, and that the information is accurate, appropriate, and makes sense.
If you believe that your report has not been submitted because you haven't received a device incident report (DIR) number, do not resubmit the report. This can create a duplicate report. Please email iris@health.gov.au to obtain the DIR number and to alert us that the system is not working as intended. -What if a user of the device reports the same incident the company has - will this create duplicates that will appear on the Database of Adverse Event Notifications (DAEN)? The TGA does its best to detect duplicate reports and will incorporate the duplicates into the one DIR number. If you become aware of a duplicate report please email iris@health.gov.au with any relevant details.
Can I use my own company's reporting form to report to the TGA?
A report to the TGA can only be accepted when reported using the TGA adverse event reporting form. Any reports not filled in correctly will be sent back to the reporter. You may attach your company's reporting form once you have placed all of the required information into the correct fields in the TGA form.
Am I able to cut and paste the information into the online report? If so how is this achieved?
Yes you are able to cut and paste information into your IRIS report.
To do this you will have to use the keyboard shortcuts. Ctrl C for copy and Ctrl V for paste.
Who can I speak to in the TGA regarding my report and subsequent investigations undertaken by the TGA?
Please ensure your company's TGA client details account is up to date, as the individuals listed in your client details are the only people the TGA investigator will be able to talk to about your report. This is to ensure confidential information is not passed onto any person other than those who work for your company. An email to iris@health.gov.au alerting us to that fact you have changed regulatory affairs officers is also beneficial for all involved.
To ensure efficient communication between the TGA and sponsors it is preferable that sponsors have a standardised or central email address to which the TGA can send information. This also ensures that the information does not get lost in any company personnel changes.
If you have any enquiries about your report please email iris@health.gov.au or call on 1800 809 361 and the IRIS team will respond.
Device ARTG number
What if I have more than one device and ARTG number involved in the incident?
Only one ARTG entry can be entered into the field designated for an ARTG number, therefore please ensure you enter the ARTG number for the device that has been identified as the 'main/primary' device in the clinical event description.
If you are unsure about which is the 'main/primary' device you should submit separate reports for each device.
All other devices involved in the incident can be entered into the 'Other devices involved section' (please remember to supply the ARTG numbers, if known, for these devices).
Note: Please be advised that the TGA will check that the ARTG number and device description match the one identified in the clinical event description. It will be changed if it is incorrect or you may be asked to clarify whether it is the correct ARTG number or device.
Why can't I see my ARTG number in the form after I have submitted it to the TGA?
Once submitted to the TGA the ARTG information entered into the adverse event form in your TGA Business Services (TBS) portal is used to search an internal ARTG lookup which auto-populates information (i.e. GMDN term, Manufacturer, etc.). There is a delay between submitting the form and the TGA updating this field.
For display purposes in the Medical Device Incident Report (MDIR) system, sponsors see the ARTG number that has been selected for the DIR and not the entered ARTG information used for searching. This is why details appear to have been removed when you initially view a submitted DIR online. There is no issue with the system.
Can I provide the company's catalogue number in place of the model number?
The TGA does not have access to any databases outside of it and thus cannot identify a device from the catalogue number information. The model number usually leads onto identifying the brand name which is important information that aids in the searching and identification of devices on the DAEN, the ARTG and within the IRIS database.
Catalogue numbers can only be given for orthopaedic devices if this number has been used in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) database. A model number/ description should also be given for any orthopaedic device.
Why do I have to supply the Implant and Explant date?
This information is important to the TGA as it gives an indication of how long the device was implanted, which could lead to a better understanding of the device, the event description and the life cycle of this kind of device.
Device description
What is the device description?
The device description is the information required to identify the device involved in the adverse event. This could be all or some of the following:
- brand name;
- model;
- serial number;
- lot number;
- kind/type of device or
- software version of the device.
Please ensure the brand/trade name is present in all reports.
Please do not use capital letters or abbreviations.
As this information will be available on the DAEN it is important that the information is clear and accurate.
Clinical event information
What is required to be placed into this section?
The information in this section must be a description of the event only. Please do not provide patient outcome or device/event analysis information in this section. There are separate sections in the reporting form for this information. Please note that the clinical event information will appear on the DAEN. Please ensure adequate and accurate information has been provided.
Please be aware that the TGA will remove/move all disclaimers and non-clinical event information from this section. Information removed by the TGA from the clinical event information is placed elsewhere within the database.
The TGA will move information into the clinical event information if it deems it relevant to the event report.
Similar events
What information are the similar events based on?
Similar events are based on the clinical event description and not the cause of an event.
What format should the similar event rates be submitted in?
If there have been other similar events reported to either the sponsor or the manufacturer enter the number of reports and the rate for Australia and worldwide. The rate of similar adverse events is required for analysis of incident trending to determine if there is an emerging issue. Therefore, providing data for a three year period separated into the year of the adverse event, one year prior and two years prior is suggested.
The rate should preferably be provided in the form of an incidence rate or percentage. The number should include the total actual number of occurrences and also the number of devices sold/supplied over the time period or since inclusion in the ARTG.
The actual incidence rate should be provided in the form of a percentage generated using the calculation (# of similar events/number supplied x 100). For example:
- In Australia:
- 12 similar events from 3,187 units (0.37%) sold in 2018;
- 10 similar events from 2,675 units (0.37%) sold in 2017;
- 2 similar events from 1,234 units (0.16%) sold in 2016.
- Worldwide:
- 235 similar events from 68,078 units sold (0.34%) in 2018;
- 325 similar events from 86,078 units sold (0.38%) in 2017;
- 253 similar events from 68,708 units sold (0.37%) in 2016.
What if the company has determined that the adverse event is not device related?
The current rates for incidents similar to the adverse event should still be provided despite it not being device related. This is to enable the TGA to have a baseline rate for the reported type of event. Regardless of whether it is device related or not this is information that is collected and thus should be available should a request be made regarding an event. If you are worried about the rate being given for something your company has deemed not device related please add your concerns to the 'rate' section.
Questionnaires
Why do I have to answer a questionnaire if the final report has most of the information in it?
Following receipt of a final report the information is risk assessed and assigned to an investigator. The investigator will, through the questionnaire or separate communication, ask for further information.
A questionnaire is usually required due to:
- conflicting or inadequate information supplied in the final report
- clarification required regarding the information supplied
- concern the response does not address the issue
The majority of questionnaires sent to the sponsor are as a result of the receipt of a report from a health care professional or consumer. Reports from these sources do not usually contain information about the analysis of the device or the incident rate for this type of device. Therefore additional information is required to satisfy the TGA and the reporter that this event was isolated, of low frequency and low risk or that the manufacturer is addressing the cause.