United StatesOmnipod 5 App Software (iOS), UDI 10385083000459, all software versions 2.X.X, distributed nationwide in the U.S. (174,013 units) is affected. The app can duplicate a single digit if a user holds the iPhone magnifier on a manual entry field while selecting a number on the keyboard, which can cause errors in manual entries (for example bolus entry, I:C ratio, bolus calculator) and may result in insulin overdelivery and hypoglycemia.
What's being recalled
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
Recalling firm: Insulet Corporation, Acton, MA, United States.
How to identify it
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
The hazard
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada