According to the American Diabetes Association (ADA), in 2007, the most recent year that data is available, a total of 23.6 million people in the United States, including children, have diabetes, which is roughly 7.8 percent of the total population of the country. Diabetes has thus been termed “America’s largest healthcare epidemic.”
Diabetes is a metabolic disease in which an individual has high blood sugar. This is because their body doesn’t produce sufficient quantities of insulin, or either because body cells don’t respond to the insulin that is being produced. If left untreated, diabetes can have serious complications, including hypoglycemia, nonketotic hyperosmolar coma, or diabetic ketoacidosis, all of which can result in death. Long-term complications can also arise from diabetes, including retinal damage, chronic renal failure, and various cardiovascular diseases. It is therefore crucial for those affected by diabetes to receive adequate treatment. However, when medications and devices that are given to diabetes patients to help treat their disease are inefficient, serious injury, illness, and even death can result.
In July of 2009, Medtronic, Inc., a medical technology company, announced a voluntary recall via the U.S. Food and Drug Administration (FDA) of certain Quick-set infusion sets used in conjunction with MiniMed Paradigm insulin pumps. An infusion set is a plastic pipe that delivers insulin to a diabetes patient from an insulin pump. Generally, it is replaced every three days.
Affected by the recall are infusion sets with reference numbers of MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with 8. According to Medtronic, an estimated two percent of Quick-set infusion sets in lot 8, roughly 60,000 infusion sets of about the three million infusion sets on the market, may not properly work. The affected infusion sets may prevent insulin pumps from venting air pressure properly, potentially resulting in the insulin pump delivering either too much or too little insulin to diabetes patients, which could lead to serious injuries or even death.
Diabetes patients are advised to stop using Quick-set infusion sets from Lot 8 immediately. No other Medtronic devices or infusion sets were involved in this recall.
If you have been affected by a defective Quick-set infusion set or faulty insulin pump, contact the defective medical device attorneys at Anapol Weiss to discuss your potential case. Call 866-735-2792 today for a free consultation.