Insulin Pump Glitch Leads to Injuries in Over 200 People with Diabetes

Published: 09 May 2024 at 17:47

Health

A software glitch in the t:connect mobile app developed by Tandem Diabetes Care has led to the recall of over 85,000 versions after causing insulin pumps to shut down unexpectedly, resulting in 224 reported injuries. The glitch, affecting Version 2.7, can cause the app to crash and restart, halting insulin delivery and potentially causing hyperglycemia or ketoacidosis. Tandem advises users to update to version 2.7.1 to prevent further incidents. Diabetes complications include blindness, kidney failure, heart disease, stroke, and amputation of extremities. No deaths have been reported as of April 15.

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Minimed Paradigm (Wikipedia)

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT (Real Time) series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.In the United States, the device is regulated by a branch of the Food and Drug Administration.

Tandem Diabetes Care (Wikipedia)

Tandem Diabetes Care is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.

Automated insulin delivery system (Wikipedia)

Automated insulin delivery systems are automated (or semi-automated) systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems (as of October 2020) can only deliver (and regulate delivery of) a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.The endocrine functionality of the pancreas is provided by islet cells which produce the hormones insulin and glucagon. Artificial pancreatic technology mimics the secretion of these hormones into the bloodstream in response to the body's changing blood glucose levels. Maintaining balanced blood sugar levels is crucial to the function of the brain, liver, and kidneys. Therefore, for people with diabetes, it is necessary that the levels be kept balanced when the body cannot produce insulin itself.Automated insulin delivery (AID) systems are often referred to using the term artificial pancreas, but the term has no precise, universally accepted definition. For uses other than automated insulin delivery, see Artificial pancreas (disambiguation).

Dexcom (Wikipedia)

DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.