A Melbourne man nearly died after an Omnipod insulin pump malfunctioned, sparking scrutiny of medical device safety as adverse event reports surge, with regulators facing calls for transparency and stricter oversight.
Tye Cummins lay in the dark, gasping for air and unable to move, after an Omnipod insulin pump delivered an overdose of insulin during sleep, plunging him into a life-threatening state. It nearly killed me,
he said, describing the ordeal that left him unable to walk or talk for hours. The incident, detailed in investigations by Theage and WAToday, highlights growing concerns about the safety of diabetes management devices, which have revolutionized care but now face scrutiny over accuracy, alarm failures, and regulatory gaps.
A Near-Fatal Incident and Its Broader Implications
Cummins’ experience is not isolated. An investigation by Theage and 60 Minutes uncovered about 81,000 adverse event reports linked to the TGA database, with diabetes management devices making up seven of the 10 devices with the most adverse-event reports submitted to the TGA since 2024. These include 429 adverse events for Omnipod 5, including 330 injuries and six cases of diabetic ketoacidosis, a severe complication requiring intensive care. The Therapeutic Goods Administration (TGA) tracks these reports but does not aggregate them publicly, leaving consumers in the dark about which devices pose the greatest risks.
They have been life-changing,
said Dr Ashley Ng, head of education and professional standards at the Australian Diabetes Educators Association, citing evidence that continuous glucose monitors (CGMs) and insulin pumps reduce complications. Yet experts warn that the TGA has eased the regulatory requirements for monitors, allowing a new generation of less-accurate devices to be sold here. US regulators have also warned patients about Bluetooth interference muting alarms, a risk Australian authorities have not addressed.
Regulatory Gaps and Manufacturer Responses
The Omnipod 5, partially subsidized by the federal government, faced a recall in Australia over an insulin-leaking issue linked to 24 serious events. Insulet, the device’s manufacturer, defended its safety, stating, Omnipod is supported by extensive clinical evidence and real-world experience across geographies demonstrating its safety, effectiveness and quality-of-life benefits for people with diabetes.
However, critics point to the device’s limitations. Professor David O’Neal, director and founder of the Diabetes Technology Research Group at the University of Melbourne, said while the monitors were not necessarily as accurate as some finger-prick meter, as a rule they are accurate enough, so that one can use them on their own without using a glucose meter to confirm the reading.
Patients are advised to check their glucose levels with a finger-prick test if they suspect the reading is inaccurate.
Associate Professor Neale Cohen, director of clinical services at the Baker Heart and Diabetes Institute, speaking to WAToday, argued that mainstream CGMs were reliable and accurate. A Victorian coronial inquest is investigating five deaths resulting from a high-profile car crash possibly linked to a CGM that failed to raise an alarm because of a Bluetooth issue.
The TGA emphasized that an adverse event report does not mean the device caused the event. More than 107,000 Australians are approved for monitor subsidy, the TGA said, and more than 146,000 people for insulin pumps.
Manufacturers, however, stress that warnings about smartphone or Bluetooth connections muting alarms and the need for periodic finger-prick checks are included in user manuals.
The Path Forward: What Comes Next?
For now, the focus remains on balancing innovation with safety. They have been life-changing,
Dr Ng said.
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