FDA issues Class I recall label to Insulet’s Omnipod Android app over incorrect bolus calculations

The FDA has handed down a Class I recall label, the agency’s most serious, to a now-corrected software issue that could have resulted in delivering ten times the desired insulin dose from Insulet’s Omnipod 5 automated pump. 

The company first issued an urgent medical device correction notice in late November of last year to users who managed their Omnipod through an Android smartphone. Insulet said it had received reports that the app’s bolus calculator was not properly recording the decimal point—potentially setting up the pump to send 3 units of insulin instead of 0.3, for example, and putting the user at risk of severe hypoglycemia.

According to the company, a software update fixing the issue was made available through Google’s app store about a week later, on December 7, 2023, to bring the Android software up to version 1.2.4. No devices needed to be returned to the company.

Insulet recommended that users should still always confirm their bolus amounts before starting the dose and that unexpected amounts can always be canceled.

The issue occurred when inputting the decimal point first into the calculator—such as typing .3 instead of 0.3 when selecting an amount under one unit of insulin.

The FDA and the company said the problem was limited to the Android smartphone app and did not occur when using the Insulet-provided Omnipod controller devices in the U.S. or its other diabetes management platforms. The company collected an FDA clearance for its Apple iPhone app to control the Omnipod 5 last October.

The agency said in its recall notice that the issue affected as many as 27,000 users, with distribution across the U.S. as well as in Germany and the U.K.

In late 2022, Insulet received a Class I rating for a recall of its the Personal Diabetes Manager handheld remote controls used with its Omnipod Dash pumps, after receiving reports of their batteries swelling, leaking fluid or overheating. At the time the company pledged to replace all 250,000 Omnipod Dash PDMs distributed in the U.S. between July 2018 and August 2022.