The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash insulin management system.
According to the notice in Europe on Nov. 2 and a news release posted on Nov. 4, the warning relates to the Omnipod Dash Personal Diabetes Manager (PDM) and its battery. Insulet said there have been 50 complaints — but no reports of serious injury or death — related to the Omnipod Dash PDM battery issues. The notice does not apply to the Omnipod Dash pods or the Omnipod insulin management system.
Some users reported battery swelling and fluid leaking from the battery. In rare cases, they reported extreme overheating, which may pose a fire hazard.
Insulet’s internal investigation determined that the PDM is at increased risk if charged to full capacity. This is particularly the case if left to charge for extended periods of time, such as overnight. The company determined an increased likelihood of this issue occurring in systems in use for more than 18 months.
The company identified an update to the PDM that addresses the issue and intends to begin shipping updated PDMs to customers in the coming months. Users will automatically receive them when they’re available.
Users should not charge their Omnipod Dash PDM if they experience the following issues and should promptly contact Insulet’s customer care team:
- The back cover of Omnipod Dash PDM bulges or can not close. Users may need to remove the PDM gel skin to observe these issues. They should not apply pressure to the back cover if deformed in any way.
- The PDM experiences extreme overheating or emits an odor while charging, during use or in storage.
- The PDM does not turn on within 45 minutes of connection to the charger, or,it turns off immediately following removal from the charger.
- Users should alert Insulet if the PDM loses charge quickly or takes longer than usual to charge.
“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,” Michael Spears, Insulet’s SVP of regulatory affairs and compliance, said in the news release.
This story originally ran on Nov. 3, 2022. Updated Nov. 7 with additional details from Insulet. Executive editor Chris Newmarker contributed to this story.
