Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.
Insulet Corp. has received 50 complaints related to batteries of Omnipod DASH Personal Diabetes Manager, including battery swelling and leakage, and in rare cases, extreme overheating and some reports of fire. The company’s investigation determined that the Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage. No serious injuries or deaths have been reported.
Insulet has identified an update and will be shipping updated devices to all current customers.
This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod Insulin Management System, or the Omnipod 5 Automated Insulin Delivery System.
“Safety is our top priority, and we have been urgently addressing this issue,” Michael Spears senior vice president, regulatory affairs & compliance, said in a press release. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”
The Omnipod DASH includes a wearable, tubeless insulin Pod that’s controlled by a smartphone-like Personal Diabetes Manager. The Pod can be worn almost and carries up to three days of insulin.