Insulet

Some Omnipod Eros pods may have damage to the soft cannula (the tiny tube that delivers insulin) caused during manufacturing. This damage can cause insulin to leak outside the pod instead of being delivered into your body. If insulin isn't delivered properly, blood glucose levels can rise to dangerous levels.

Some Omnipod DASH Pods have a manufacturing defect in the soft cannula (the tiny tube that delivers insulin) that can cause insulin to leak around the pod instead of into your body. This means you may receive less insulin than needed, which can lead to high blood sugar levels.

Some Omnipod 5 insulin pump pods have a manufacturing defect in the soft cannula (the small tube that delivers insulin) that can cause insulin to leak outside the pod instead of being delivered into the body. This under-delivery of insulin can lead to high blood sugar levels. In severe cases, prolonged high blood sugar can result in diabetic ketoacidosis or other serious complications.

Certain Omnipod 5 Pods from 49 specific manufacturing lots contain an internal tear in the soft cannula. This defect causes insulin to leak inside the Pod instead of being delivered to your body. In some cases, the Pod may shut down completely and stop delivering insulin, or deliver less insulin than needed.

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.