Recall notice
Omnipod Alternate Controller Insulin Pump recalled for Insulin Leakage Issue, USA
4 days ago •source fda.gov
United States
Insulet Corporation (NASDAQ: PODD) ("Insulet" or the "Company") today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States. Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA.Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended.
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.
This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.
Customers should visit the Omnipod website to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.
The U.S. Food and Drug Administration (FDA) has been notified of this action.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us
Comments
Comment