Nearly 30 Serious Injuries Tied to Recalled Insulin Pods, FDA Says

Omnipod 5 insulin delivery pods subject to a class I recall have been linked to nearly 30 serious injuries, the FDA said on Thursday.

The agency reiterated that patients should not use pods from 49 affected lots that may have a small tear in the internal tubing, which may cause insulin to leak inside the pod, leading to under-delivery of medication.

When the voluntary recall was initiated on March 12, manufacturer Insulet had received 18 reports of serious adverse events tied to hyperglycemia, including hospitalization and diabetic ketoacidosis (DKA).

As of April 17, Insulet has reported 29 serious injuries and no deaths associated with this issue, the FDA said. (An agency communication on Wednesday erroneously reported the number of serious injuries; that number has since been corrected.)

“If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin,” the FDA said. “In the most severe cases, prolonged and persistent high blood glucose levels can lead to DKA, a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.”

The risk of under-delivery increases if users apply more than one affected pod in a row, the agency noted.

Healthcare providers should discuss other methods of insulin delivery with patients who are waiting for replacement pods. Patients should confirm that new pods are not from affected lots and should not use any pod after its expiration date.

In some cases of a leak, users may receive a hazard alarm instructing them to remove it. However, patients may not always receive an alert, leading the issue to go unnoticed.

“Because this problem may happen without triggering an alarm or alert, users could receive less insulin than needed without realizing it,” the agency stated. “For this reason, affected users should not rely only on alarms to know if something is wrong.”

The waterproof pods, worn for up to 72 hours, are part of the Omnipod 5 automated insulin delivery system indicated for both type 1 and type 2 diabetes. It is the first tubeless hybrid closed-loop system that works with Dexcom G6/G7 and FreeStyle Libre 2 Plus continuous glucose monitoring systems.

The issue does not extend to continuous glucose monitoring systems or their readings.

Patients can request replacement pods and receive additional support here.