The Food and Drug Administration (FDA) has issued a recall for the OmniPod Insulin Management System. It is a device that allows diabetics to conveniently and effortlessly deliver insulin. The insulin pump is self-contained and attaches to the patient’s skin. The device primes automatically, and inserts insulin through a small automated needle. The dosage and frequency of insulin delivery is monitored through a portable electronic device.
Issues with these devices:
- The tube either fails to fully insert into the skin or completely retracts after insertion. This failure occurs without an alarm and the Pod will continue to pump insulin.
- The Pod will provide an audible alarm signal and display a failure. Once the alarm occurs, the Pod will not pump insulin.
Both failures can result in inaccurate dosage of insulin which can lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or event death.
- What is hyperglycemia? High blood sugar.
- What causes hyperglycemia? If your body does not receive enough insulin, glucose builds up in your bloodstream.
- What is it dangerous? Persistent hyperglycemia causes complications damaging your eyes, kidneys, nerves and heart. If left untreated, hyperglycemia can result in diabetic ketoacidosis (DKA).
- What is the treatment for hyperglycemia? Adjusting insulin to control hyperglycemia. Severe hyperglycemia warrants emergency treatment in the emergency room or admission to the hospital.
Houssiere, Durant & Houssiere, LLP is currently obtaining cases for the OmniPod Insulin Management System. If you or somebody you know was injured by this product, you should contact our lawyers immediately for a free case consultation. Please contact our office (713) 626-3700 or call us toll-free at (888) 881-8100.