Medtronic MiniMed 670G Pump Failure Resulted in Hypoglycemic Episode and Fall, Lawsuit Alleges

According to allegations raised in a recently filed product liability lawsuit, the failure of a Medtronic MiniMed 670G pump caused a Pennsylvania woman to lose consciousness and fall, after the device delivered inappropriate levels of insulin that resulted in a hypoglycemic event.

The complaint (PDF) was filed by Carol Sheldon in the U.S. District Court for the Middle District of Pennsylvania on November 18, indicating that Medtronic manufactured an unreasonably dangerous and defective insulin pump, which has since been the subject of a massive recall.

Sheldon is a Type 1 Diabetic, who began using a Medtronic MiniMed Model 670G insulin pump in June 2018, to help regulate her blood sugar. On November 18, 2018, Sheldon was at her Pennsylvania home when the Medtronic insulin pump indicated that her blood sugar was low. As a result of the alert, she headed toward the kitchen to obtain food, but suffered a hypoglycemic episode that caused her to pass out and fall.

The lawsuit maintains that the fall and subsequent injuries were a direct result of the Medtronic Minimed pump failing, leaving her with serious injuries, including a broken foot, toenails torn off of her foot, and a traumatic brain injury from the impact of the fall.

Sheldon was treated at a nearby hospital, where she was informed that she suffered a severe hypoglycemia event, resulting in seizures and a diabetic coma.

Medtronic Minimed Problems

The Medtronic Minimed insulin pumps are small, computerized devices that deliver insulin to diabetic patients throughout the day, via a catheter implanted under the skin. They are wirelessly connected to both the patient’s blood glucose meter and a monitoring system to track glucose levels, as well as a remote controller that is designed to communicate with the pump and deliver a specific amount of insulin.

When functioning properly, these devices and their components mimic the ways a healthy pancreas works by delivering continuous and controlled doses of rapid-acting insulin, 24 hours a day, to match the user’s body needs.

The case raises allegations similar to those presented in a growing number of Medtronic Minimed lawsuits, claiming that the manufacturer knew or should have known that defects with the 600 series insulin pumps posed a serious risk for consumers.

Sheldon indicates that Medtronic Inc. submitted a defect notice to the FDA in November 2019, in which the manufacturer admitted certain series insulin pumps contained a defect in the locking retainer rings, including the Model 670G. This could prevent a patient’s insulin reservoir from being properly seated within the pump when loaded.

The information prompted the FDA to issue the Class I Medtronic MiniMed pump recall, which impacted roughly 300,000 insulin pumps distributed since September 2016, including the MiniMed 670G model Sheldon was using at the time of the incident.

Medtronic acknowledged at that time that it was aware of at least 26,421 complaints in which the insulin pump over or under delivered the programmed amount of insulin, resulting in 2,175 injuries and at least one death.

Over the coming weeks and months, as product liability lawyers continue to investigate claims for individuals who experienced problems after a Medtronic Minimed pump failure, the size and scope of the litigation is expected to continue to increase, likely involving hundreds of lawsuits that may be filed in courts nationwide.