Urgent Product Recall Issued for Insulin Device Which Could Catch on Fire

Omnipod Dash Personal Diabetes Manager PDM Insulin Device Product Safety Australia Australian Competition and Consumer Commission ACCC

By Camille Hutchison , Parent Herald Nov 13, 04:11 am

An urgent product recall has been issued for a device designed to administer insulin to individuals with diabetes, due to fears and suspicions that it might swell, leak fluid, overheat and eventually catch on fire.

The Omnipod Dash Personal Diabetes Manager (PDM) is a wearable device that delivers up to three days of insulin without any need for injections. Hence, Product Safety Australia has advised that if the battery pack overheats, the device could result in a fire which can surely cause severe injury or death.

Product Safety Australia released a statement that if the PDM turns out to be inoperable, there may be a delay in therapy. Thus, if insulin delivery is suspended, it may lead to major hyperglycemia which can result in severe health complications. Additionally, in serious cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalization or intervention from a medical professional.

Users are warned and encouraged not to charge the PDM if the battery compartment is bulging as the device could result in overheating. Moreover, if the device does not turn on within 45 minutes of being connected with the charger or doesn't turn off immediately after being unplugged, it should not be charged.

Do not charge the device overnight

The Product Safety Australia website, managed by the Australian Competition and Consumer Commission (ACCC) on behalf of Commonwealth and state and territory regulators has the main role to identify and address the risk of serious injury and death from safety hazards in consumer products. It warned individuals to not charge the device when the surrounding temperature is more than 31C or in direct sunlight.

It also has an indicated warning that states to never use the device while charging or feels unusually warm. Product Safety Australia also stated that devices can continue to be used if the battery is not charged to approximately more than 85 percent of capacity. They also warned not to charge the device overnight as it can damage the battery which could trigger an adverse outcome.

Moreover, 9 News reported that the Insulet Corporation, the company that produces PDM, is not implementing a software change that would limit the charging capacity. Noting that the updated devices will be shipped in the coming months. To date, there have been 455 customer complaints worldwide, including 25 "adverse events." No reports have been made in Australia regarding the device.

How does an insulin device work?

An insulin device provides continuous delivery of short-acting insulin all day long. This replaces the need for various and multiple daily injections with a constant insulin infusion as well as helps to improve blood sugar levels. This device is computerized so that it mimics the way human pancreas works by gradually delivering small doses of short-acting insulin continuously.

In fact, all types of insulin produce the same effect as they are all used to mimic the natural enlargements and reductions of insulin levels in the body during the day. Keep in mind that there are factors in how different types of insulin affects how fast and how long they work, per Healthline.