Medtronic MiniMed insulin pumps are indicated to deliver insulin in patients who suffer from Type 1 diabetes. Certain MiniMed pumps – Models 630G and 670G – were recalled in November 2019 because of a defect that had been implicated in at least one patient death and more than 2,000 injuries. The U.S. Food & Drug Administration (FDA) later designated the Medtronic MiniMed recall a Class I medical device recall, it’s most serious category.
Type 1 diabetes occurs when the pancreas is unable to produce insulin.
According to the American Diabetes Association, approximately 1.25 million people in the United States are currently living with Type 1 diabetes, while around 40,000 are newly diagnosed every year.
Insulin is a hormone that helps the body control and use glucose (sugar), a key source of energy that comes from carbohydrates. Keeping glucose under control not only helps people feel better on a daily basis, but also prevents long-term complications, such as blindness, kidney failure, and heart disease.
People with Type 1 diabetes require insulin therapy. They may self-administer daily injections of insulin or opt for an insulin pump that provides a continuous insulin infusion throughout the day. Insulin pumps may be especially advantageous for those who:
Medtronic MiniMed insulin pumps are about the size of a smartphone and can be easily carried on a belt, inside a pocket, or attached to a bra. A reservoir inside the pump is filled with insulin. From there, the insulin travels along a thin tube and is “infused” into the body through an infusion set that has been inserted into the skin.
Recent additions to Medtronic’s line of MiniMed insulin pumps include:
The FDA approved the Medtronic MiniMed 670G System in September 2016, while the MiniMed 630G System was approved in June 2017. Each consists of a continuous glucose monitor (CGM) that measures the user’s glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the CGM.
In November 2019, Medtronic recalled certain MiniMed 600 Series Insulin Pumps because a retainer ring used to lock the insulin cartridge into the pump’s reservoir was either missing or broken. The Medtronic MiniMed recall affected more than 322,000 insulin pumps sold in the United States, including:
According to Medtronic, if the insulin cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.
By the time the MiniMed insulin pump recall was announced, Medtronic had already received more than 26,4oo complaints of malfunctions related to a broken or missing retainer ring. The firm was also aware of 2,175 patient injuries and 1 death.
In February 2020, the FDA declared the Medtronic MiniMed recall Class 1, a designation that indicates use of product may cause serious injury or death.
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