Omnipod DASH

2022: Devices found to be defective

On October 17, 2022, Insulet said it had received reports that some Omnipod DASH users had problems with the batteries of their PDM devices, including a bloating battery, leaking liquid from the battery and, in rare cases, severe overheating. The company said it had not yet received reports of any injuries related to battery problems.

The battery problem applies to all Omnipod DASH PDM devices from Insulet, but the likelihood of problems can increase if the device is used for longer than 18 months. Charging the device to a full battery charge and leaving it on the charger overnight also raises the risk. Insulet management cited higher warranty costs related to the Omnipod DASH PDM in its earnings call for the second quarter of 2022.

Omnipod DASH

The developers advised patients to monitor their PDM for battery problems, including a bulging back cover, rapid loss of charge, overheating or an unpleasant odor in the device. In the event that patients notice any of these problems, they should not charge the device, stop using the system, and switch to a backup insulin plan as soon as possible. Users can also contact Insulet to obtain a temporary replacement for the device. In a letter to users, the company said it plans to send updated devices to all current Omnipod DASH customers by the end of 2023.

The developers have released an urgent fix for medical devices related to battery problems in the Omnipod DASH system component. According to J.P. Morgan analyst Robbie Marcus, Insulet plans to replace PDM for all Omnipod DASH users around the world, which will entail a total cost of $35 million to 45 million,^[1]

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