Frequently asked questions about filling in a device incident report

12 December 2013
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If you are unsure of what is required once you have read this document please email iris@tga.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 possible sections and that the information is accurate, appropriate and makes sense.

Do not resend a report if you haven't received a 'DIR' number. This can create a duplicate report. Please email iris@tga.gov.au to obtain the DIR number and to alert us that the system is not working as intended.

The TGA does its best to detect this and will incorporate duplicate reports into the one DIR number. If you become aware of a duplicate report please email iris@tga.gov.au with any relevant details.

Please note that no other forms are accepted. A report to the TGA can only be accepted by using the IRIS 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 IRIS form.

Yes you are able to cut and paste your information into your IRIS report.

To do this you will have to use the Keyboard shortcuts. Ctrl C for cut and Ctrl V for paste.

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 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 alerting us to that fact you have changed regulatory affairs officers is also beneficial for all involved.

To ensure efficient communication between 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@tga.gov.au and the IRIS team will respond.

Device ARTG number

Only one ARTG entry can be entered, 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 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.

Once submitted to the TGA the ARTG information entered into the adverse event form in your ebs 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 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.

The TGA does not have access to any company model databases and thus cannot identify a device from the model 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.

Model numbers can be given for the device model; this is especially helpful information for orthopaedic devices.

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

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 and
  • 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

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 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 also reserves the right to move information into the clinical event information if it deems it relevant to the event report.

Similar events

Similar events are based on the clinical event description and not the cause of an event. You will need to submit the similar event rates for the issue identified in the clinical event description.

If there have been other similar events reported to either the sponsor or the manufacturer enter the number of reports or the rate. The rate should preferably be provided in the form of an incidence rate or percentage. If the number of events is provided, the number supplied must also be provided, for example 12 of 3,000 units sold over two years in Australia or 25 of 5 million units sold over 5 years worldwide. If there have been no similar events write "0" or "nil".

Examples of the way the rate should be presented are below:

  1. 2 similar events out of 56000 supplied = 0.00357% or 0.0000357(rate)
  2. 10 similar events out of 100,000 supplied = 0.01%
  3. 2 similar events out of 45 = 0.044 or 4.4% (If the device has small numbers of supply because it is a reusable device please indicate this)

Please indicate if the number supplied is a rate otherwise the TGA will convert it to a percentage.

The current rates for incidents similar to this 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

Following receipt of a final report the information is risk assessed and the report may be further reviewed by an internal committee 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.