On August 27 2015, the Food and Drug Administration (FDA) announced a recall of 40,846 boxes of the Insulet OmniPod insulin management system. The Insulet OmniPod were defectively manufactured between December 2013 and March 2015.
The FDA announced recalls for OmniPods with the following lot numbers:
Insulet OmniPods are a continuous insulin delivery system administered via a pod worn on the skin, delivering insulin in a process known as continuous subcutaneous insulin infusion (CSII) therapy. Insulin pumps like the Insulet OmniPod consist of three main components inside the plastic shell. The components include the pump (with batteries, controls and modules), the insulin reservoir delivered to the bloodstream, and a retractable needle known as a cannula.
The Insulet Omnipod is used in conjunction with the Insulet Personal Diabetes Manager, a small hand-held electronic device used to manage diabetes treatment. In 2014, the FDA announced a recall for Abbott FreeStyle diabetes test strips and the FreeStyle monitor system built into some models of the Insulet Personal Diabetes Manager.
Insulet OmniPod FDA recallThe FDA warns OmniPod users the device could fail in one of two ways:
- The cannula, a tube that can be inserted into the body, may either retract or fail to fully deploy.
- Insulet OmniPod may trigger an alarm indicating the Pod will no longer deliver insulin and will need to be replaced.
Complications associated with using defective Insulet OmniPod insulin delivery systems include developing hyperglycemia, an excess of glucose in the bloodstream. Hyperglycemia may result in the patient suffering ketoacidosis, a condition in which the body cannot produce enough insulin to properly metabolize blood acids.
Ketoacidosis is a serious medical condition. Serious complications associated with ketoacidosis include:
- Diabetic coma
- Swelling of the brain
Insulet OmniPod injury lawsuit
If you or a family member suffered a serious injury while using the Insulet OmniPod insulin pump as part your diabetes management and treatment, it may have been caused by a defectively manufactured Insulet OmniPod. Our attorneys offer free case reviews for individuals thinking about filing an Insulet OmniPod personal injury lawsuit.
The product liability and personal injury attorneys of The Cochran Firm, D.C. are actively investigating claims of diabetes patients being seriously injured by faulty Insulet OmniPods. Our seasoned attorneys can help you and your family recover for lost wages, hospital bills, medical expenses, pain and suffering and other damages.
We take our cases on a contingency basis. This means we do not collect any legal fees or payments from you unless we win your case.
Call our office on our local number at 202-682-5800 during business hours or at 1-800-THE FIRM (843-3476) to reach us 24 hours a day. You can also fill out a contact form on our website. Strict time deadlines apply when filing an Insulet OmniPod injury lawsuit so please contact us at your earliest convenience and protect your rights.