An urgent recall has been issued for a device designed to administer insulin to people with diabetes, with fears it may swell, leak fluid, overheat or catch on fire.
The Omnipod DASH personal diabetes manager (PDM) is a wearable device that provides up to three days of insulin delivery without the need for injections.
But Product Safety Australia has warned if the battery pack overheats, it could result in a fire “which can cause serious injury or death”.
“Additionally, if the PDM becomes inoperable there may be a delay in therapy. If insulin delivery is suspended, this may lead to major hyperglycemia which can result in serious health complications,” a statement from Product Safety Australia reads.
“In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.”
Users are warned they should not charge the PDM if the battery compartment is bulging, the device is overheating, or it does not turn on within 45 minutes of being connected with the charger or turns off immediately after being unplugged.
Product Safety Australia said devices can continue to be used if the battery is not charged to more than 85 per cent capacity.
“Do not charge the device overnight,” the warning reads.
They also warn the device should not be charged when the surrounding temperature is more than 31C or in direct sunlight.
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“Do not use PDM while charging,” the warning states.
“Do not charge the PDM when it feels unusually warm.”
The company that makes the PDMs, Insulet Corporation, is implementing a software change that would limit the charging capacity.
The updated devices will be shipped “in the coming months”.
There have been 455 customer complaints worldwide, including 25 “adverse events”.
No reports have been made in Australia regarding the device.
