Recall Alert

The OmniPod (Pod) Insulin Management System is a medical device used by diabetes patients to deliver life-saving insulin doses. According to the U.S. Food and Drug Administration (FDA), the maker of OmniPod, Insulet Corporation, recently initiated the recall of 40,846 boxes of the OmniPod Insulin Management System. The boxes contain 10 pods per box. The recall was initiated due to the danger that certain pods could fail to deliver appropriate doses of insulin.

Defective OmniPods Can Fail in 2 Ways

According to the FDA, the pods can fail in two different ways. The cannula, or syringe, which delivers insulin from the pod, might fail to deploy completely. This can cause the patient to not receive the appropriate amount of insulin. Alternatively, an audible alarm might be engaged in the device, indicating that the mechanism is not delivering insulin. In both of these events, patients might not get sufficient insulin, which can cause hyperglycemia and, in more extreme cases, diabetic ketoacidosis (DKA).

Defective OmniPod lots have been blamed for 13 patients requiring medical intervention. Also, 90 Medical Device Reports have been filed relating to the device failures. Fortunately, no deaths or serious injuries have been reported relating to this recall so far.

Check FDA Website for More Information About Affected Lots

Patients should check the FDA notice to determine if they are in possession of potentially dangerous pods. The FDA has listed affected lot numbers. The numbers can be found on OmniPod tray lids. They are laser-etched into the sides of every pod as well.

Seek Assistance from a Personal Injury Attorney if Necessary

OmniPod users who suspect that they may have suffered a serious medical event due to dangerous defects relating to their OmniPods, should seek a medical evaluation of their injuries immediately. After stabilizing their conditions, they may also want to consult with a personal injury attorney to investigate the possibility of pursuing a claim for financial damages relating to any resulting injuries.

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