Insulet Corporation has issued a safety alert involving potential malfunction of its OmniPod (Pod) Insulin Management System. According to a Nov. 2 notification, 15 lots of the Pod may have issues with needle deployment, where the needle may fail to deploy or deploy slowly. As a result, insulin may not be delivered properly and patients may suffer hyperglycemia and diabetic ketoacidosis (DKA). The safety alert cites at least 66 Medical Device Reports related to this issue. Three cases required medical intervention.
The needle mechanism defect occurs at a rate of about 1 percent to 2 percent in the affected lots. After discovering the issue, Insulet revised the manufacturing process and implemented additional inspection steps, according to the alert. The recall does not affect the OmniPod Personal Diabetes Manager (PDM).
Diabetes leads to high levels of sugar in the blood. In type 1 diabetes, the body produce little or no insulin, a hormone that signals cells to take up glucose. In type 2 diabetes, insulin is not being used properly, often as a result of insulin becoming desensitized. Without proper use of insulin, cells are unable to take up glucose for energy and fat is burned instead. Ketone bodies, a product of fat breakdown, can change the pH of the blood and lead to DKA. Symptoms of DKA may include dry or flushed skin, a fruity odor on the breath, difficulty breathing, nausea, vomiting, abdominal pain and dry or flushed skin. This condition can lead to a diabetic coma or death if untreated.
from Parker Waichman http://www.yourlawyer.com/blog/insulet-warns-of-needle-deployment-problems-with-omnipod-insulin-management-system/
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