A South Carolina woman who recently filed suit against Medtronic, Inc. claims a malfunctioning Model 630G MiniMed Insulin Pump left her in a diabetic coma.
According to a complaint filed in the U.S. District Court, District of South Carolina, on February 20th, Martha Schwartz refilled her insulin pump before going to bed one night in February 2017. But something went wrong and she received the entire dose of insulin at once, resulting in a sudden drop in blood sugar. While Schwartz ate some honey in an attempt to restore her blood sugar to a normal level, she fell into unconsciousness for the rest of the night. (Case No. 8:20-cv-00804-BHH)
The following morning, Schwartz was disoriented, confused and experiencing impaired vision. She also noted pain, bruises, cuts and other injuries that suggested she had suffered hypoglycemic seizures while unconscious.
“Defendants’ products were not fit for the ordinary purpose for which such goods were used. They were unmerchantable when used as directed and defective in design, and the Defendants’ failure to provide adequate warnings and instructions also resulted in said products being unreasonably dangerous,” the South Carolina lawsuit states. “Defendants’ products were dangerous to an extent beyond the expectations of ordinary consumers with common knowledge of the product’s characteristics, including Mara Schwartz.”
In November 2019, Medtronic notified customers of a possible defect affecting some 322,000 Model 630G and Model 670G MiniMed Insulin Pumps.
“Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment,” Medtronic warned. “If the 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.”
Schwartz now believes this defect caused her MiniMed Insulin Pump to malfunction. However, she only became aware that the pump was unreasonably dangerous and had contributed to her injury after the recall was publicized.
In February 2020, the U.S. Food & Drug Administration designated the Medtronic MiniMed Insulin Pump recall a Class I medical device recall – the most serious category. According to the agency, a missing or broken retainer ring has been implicated in at least one death and more than 2,100 injuries. Medtronic has also received over 26,400 complaints of MiniMed pump malfunctions related to this defect.