Product defect to hurt uptake of next gen diabetes technology

MedTech News: Subsidising a next generation technology for diabetes care has meant freedom of choice for patients as well as the freedom from wires and tubes. However, a product defect alert issued by the Therapeutic Goods Administration (TGA) will slow down the uptake of this new medical technology that is set to be added to National Diabetes Services Scheme (NDSS) from 1st December.

Insulet Australia has received reports of problems with the Omnipod DASH Personal Diabetes Manager (PDM). These include battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard. The potential harms are burns, exposure to toxins and delay in a patient’s insulin therapy.

According to the company “Our investigation has determined that the Omnipod DASH PDM is at increased risk if charged to full capacity, particularly if left to charge for extended periods of time (e.g. overnight). Omnipod DASH PDMs in use more than 18 months may have an increased likelihood of this issue occurring.”

Diabetes Australia and the diabetes community advocated for the inclusion of Omnipod DASH on the NDSS in the last couple of years. The Omnipod DASH Insulin Management System uses a tubeless, wearable and waterproof pod that is integrated with a small handheld Personal Diabetes Manager to provide calibrated delivery of insulin over a 72-hour period. The pods are disposable and replaced every three days. Patients have been paying over $400 per month for the pod and touchscreen device and have been looking forward to the NDSS listing.

According to the TGA , Insulet will be implementing a software change to update the PDM to limit the charging capacity to reduce the risk of overcharging. Insulet expects your updated Omnipod DASH PDM to be available by June 2023. Patients do not need to call to receive an updated Omnipod DASH PDM. One will automatically be shipped to them when it is available next year.

The TGA has confirmed that at this time the Omnipod DASH PDMs are not being recalled from the market.

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