Device intended for the subcutaneous delivery of insulin into a patient
Product details
- Device intended for the subcutaneous delivery of insulin into a patient
Company announcement
Insulet Corporation is initiating a voluntary medical device correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue that could result in insulin under-delivery.
The affected Pods may have a small tear in the tubing, leading to insulin leakage and potentially high blood glucose levels.
Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported.
Risk:
If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.
Impacted states: Nationwide
Products:
- Omnipod® 5 Pods
- Omnipod DASH® Pods
- Omnipod® Insulin Management System (Omnipod Eros) Pods
Contact
For more information, call 1-800-641-2049.