Paradigm Insulin Pump
Insulin pumps are small computerized devices used to help treat patients living with Diabetes. The pumps are designed to be able to deliver insulin in a steady measured and continuous dose called basal insulin, or as a surge dose called a bolus dose. The insulin pump can be adjusted by the individual, and is used around mealtimes.
The insulin pump has a flexible plastic tube called a catheter through with the insulin doses are delivered. A small needle appendage on the end of the catheter allows it to pierce the skin into the fatty tissue and is then taped into place to allow the insulin to be pumped into the bloodstream. A person with Diabetes must still monitor his or her blood glucose levels even when using an insulin pump as insulin levels can be abnormal due to an outside cause.
The American Diabetes Association lists the advantages of using an insulin pump as: eliminating individual insulin injections, delivering insulin more accurately than injections, improving A1C ( test that determines average blood glucose level), fewer swings in blood glucose levels, delivering bolus insulin easier, allowing people to be more flexible about when and what they eat, reducing severe low blood glucose episodes, eliminating unpredictable effects of intermediate or long-acting insulin, and allowing people to exercise without having to eat large amounts of carbohydrates.
Many Diabetics use insulin pumps to assist with their daily struggle to maintain normal insulin levels. If the device malfunctions, the user may face severe consequences.
This past June, Medtronic, the world’s largest medical technology company based in Minneapolis, issued a warning that a mechanical issue involving its Paradigm insulin pump could lead to the delivery of too much or too little insulin. The exact issue is with a part in the Paradigm infusion set, which is used in conjunction with the Paradigm insulin pump to deliver an insulin dose. The part has a deficiency, in that fluids can temporarily block the vents that allow the pump to work properly.
After Medtronic issued the warning, the U.S. Food and Drug Administration (FDA) later upgraded it to a Class I recall, the agency’s most serious classification. The FDA stated that patients could get very sick from either hypoglycemia or hyperglycemia due to the over or under-delivery of doses of insulin.
The recalled Paradigm insulin pumps are the October 2001 through June 2013 models, and were distributed between December 2001 and June 2013. Individuals who own the recalled product are directed to not insert the affected infusion set and to call for assistance if they notice anything unusual about the product. A major red flag includes insulin continuing to drip from the tip of the infusion set after priming is completed.
Health professionals and patients using medical devices are strongly encouraged to report any adverse effects or problems through the FDA’s MedWatch system. Diabetic patients are seriously encouraged to be extra careful when examining the functionality of the insulin pumps, especially since other issues with Medtronic have been uncovered. In April, an Australian safety advisory focused on 9 separate models of Medtronic’s Paradigm insulin pumps due to loose parts and sensor graph malfunctioning.
Medtronic has also recently issued four warnings about its SynchroMed infusion drug delivery pumps. These warning led to more FDA recalls and have been deemed responsible for 14 deaths over the past 17 years.
At Sheff Law, we are a team of attorneys and legal professionals dedicated to providing the best possible representation to our clients. We have the resources, experience, and national reputation to investigate injuries resulting from defective insulin pumps. If you woud like to contact an attorney at Sheff Law today please fill out a fill out the free consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog