Reporting a problem with a diabetes medical device What is a diabetes medical device? Diabetes medical devices are technology designed specifically to help manage diabetes. They include devices that help you check your blood glucose levels (BGLs) or give insulin. For example: Blood glucose monitors Flash glucose monitors Continuous glucose monitors (CGM) Insulin pumps, including tubeless patch pumps. These devices are essential tools for people living with diabetes, helping to monitor and manage diabetes, reduce the risk of complications and live well. What is a medical device adverse event? No diabetes medical device is completely risk free. At times, you may experience some problems with your device. A medical device adverse event is a problem that led or could have led to serious illness, injury, admission to hospital or death. This could include: a device alarm not sounding when it should a device incorrectly delivering therapy (wrong dose of medication or treatment) problems with devices causing ongoing pain, infection, wound swelling inaccurate blood glucose monitors. What to do if you experience an adverse event If you are concerned about your diabetes medical device, talk to your doctor or healthcare team. Your healthcare professional or facility can help you report an adverse event or may report on your behalf. If you experience an adverse event in a hospital or healthcare facility, tell the facility as soon as possible. You can also make a report to the Therapeutic Goods Administration (TGA). The TGA monitor the safety of medical devices approved for supply in Australia. Reporting an adverse event You can report problems with your diabetes medical device directly to the TGA through an online form. If you need help, call the TGA’s free phoneline 1800 809 361. You do not need to be certain that the problem is linked to your medical device, just suspicious. Every report to the TGA is important. Your report should include information about: You or the person you are reporting for – age, gender, any underlying health conditions. The device you are reporting about – brand and model name, Australian Register of Therapeutic Goods (ARTG) number (if known), serial number, batch or lot number. A photo of the device’s packaging on all sides works too. The problem/incident – what happened, when it started and stopped , where did it take place (in your home, a healthcare facility), what you have done to manage it or any symptoms that you are experiencing. Give as much detail as you can. It will help the TGA to follow up with the medical device manufacturer and Australian supplier. Your medical records may have information about your device if you do not have it available. You may need to ask your health professional or healthcare facility for some details. What happens next? The information you provide in a report will help the TGA monitor the ongoing safety of the device. All reports are assessed and included in the Incident Report Investigation Scheme. Reports are reviewed and risk-accessed to identify events that have a significant risk of harm to the Australian public, where timely intervention and action is critical, or consider whether the manufacturer’s investigations and actions are sufficient in minimising risk. When concerns or issues with products are identified they are published as safety alerts. More information You can find more information about reporting medical device adverse events on the TGA website: Report an adverse event or problem (consumers) Report an adverse event or problem (health professionals) Medical Device Incident Report online form (consumer)
