Alternate controller enabled insulin infusion pump
Product details
- Alternate controller enabled insulin infusion pump
Company announcement
Insulet Corporation initiated a voluntary medical device correction for specific lots of Omnipod® 5 Pods due to a manufacturing issue.
Certain Pods may have a small tear in the internal tubing, leading to insulin leakage inside the Pod instead of being fully infused into the body.
This issue affects specific identified lots distributed in the United States.
The company has received 18 reports of serious adverse events, including hospitalization and DKA, but 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.
Impacted states: Nationwide
Products:
- Omnipod® 5 Pods
Contact
For more information, call 1-800-641-2049.