Medtronic PLC Issues Insulin Infusion Set Recall Amid Hypoglycemia Fears. Medtronic PLC, a medical device company, is based in Ireland and one of the largest medical device manufacturers in the world, issue a recall for infusion sets used with its insulin pumps in September 2017. Medtronic issued a voluntary recall for particular groups of infusion sets […]
Medtronic PLC Issues Insulin Infusion Set Recall Amid Hypoglycemia Fears. Medtronic PLC, a medical device company, is based in Ireland and one of the largest medical device manufacturers in the world, issue a recall for infusion sets used with its insulin pumps in September 2017. Medtronic issued a voluntary recall for particular groups of infusion sets across its entire inventory because the company learned that the device could malfunction. Any malfunction in an insulin pump could lead to the patient suffering from acute hypoglycemia which is a severe and potentially lethal medical condition. The latest recall is another in a long line of Medtronic insulin pump recalls and failures from which at least two people have died.
Parker Waichman LLP is a national law firm dedicated to holding medical device companies responsible for putting profit over consumer safety. Parker Waichman’s medical device defect lawyers are currently investigating Medtronic device failures and the injuries people have suffered from Medtronic’s refusal and failure to research, design, and manufacture their insulin pumps properly.
In September of 2017, Medtronic issued a voluntary recall of its MiniMedinfusion sets. The company claims that the infusion sets are no longer in use. However, the recall involved infusion sets used with all of its insulin pump models. Medtronic stated that the recall excludes the glucose sensors as well as the pumps and is strictly limited to the MiniMed infusion set.
Medtronic announced the voluntary recall with the assistance of the U.S. Food and Drug Administration (FDA). The FDA voluntarily assists medical device manufacturers with the distribution of recall notices to protect the public. Medtronic warned its customers in the recall announcement that the covering on the vent of the questioned infusion devices can become blocked or clogged during the procedure of filling the infusion tube or priming the infusion tube with medication. The blockage typically happens after the patient changes the device. Medtronic found blockage occurs most frequently when a liquid is spilled onto the insulin reservoir.If this occurs, then the glucose meter could read the patient as needing an immediate dose of insulin. The pump then delivers insulin based on the perceived need. The patient could go into a state of hypoglycemia or a state of low blood glucose (sugar).
Medtronicinstituted the voluntary recall after receiving notice of people falling into a state of hypoglycemia requiring hospitalization.
Hypoglycemia is a dangerous medical condition. Symptoms of hypoglycemia include irritability, sweatiness, pounding heart, vision problems, and unclear thinking. Severe hypoglycemia can lead to a loss of consciousness, seizures, coma, and rarely death. Doctors warn that severe hypoglycemia is not a trifling condition and can be especially dangerous when operating a motor vehicle. Diabetic drivers who fall into hypoglycemia run the risk of passing out behind the wheel or suffering from a seizure. Naturally, if any condition strikes while driving, the afflicted person will lose control of the car, thereby endangering themselves and everyone around them. Additionally, physicians show concern about people walking down a flight of stairs in a hypoglycemic state because the patient might fall. Diabetic patients must be concerned about prolonged hypoglycemic states and loss of consciousness due to the potential of suffering from brain damage.
The recall notice distributed by Medtronic counseled consumers to investigate which model they were currently using and comparing it to the list of infusion sets about which Medtronic received complaints. Medtronic indicated in its release that it would pay for the cost of replacing the infusion sets.
The recalled infusion sets were in use up to April of 2017. Since then, Medtronic redesigned the infusion set to account for and correct the problem. Medtronic claims that its new design “reduces the risk,” but does not eliminate, the chance of an insulin pump over-medicated the patient.
In 2013, the FDA issued a Class 1 recall of the MiniMed infusion sets used in conjunction with the Paradigm Insulin Pump. This recall affected 11 million units worldwide, including the U.S.
A Class 1 FDA recall is the most urgent recall notice issued by the FDA. The FDA announces a Class 1 recall when it determines that there is a “reasonable probability” using the device can cause serious health consequences, including thedeath of the user.
A malfunction similar to the most recent recall led to the 2013 Class 1 recall. In 2013, the MiniMed infusion set would malfunction if a liquid came invaded the inside of the Paradigm infusion set. If this happened, the pump would deliver an inappropriate amount of insulin at that time. The FDA determined that the recall was based on a faulty device design.
In July of 2013, Medtronicalerted consumers to a problem with the reservoir itself. Certain lots of the reservoir used with the Paradigm pumps leaked fluid. Medtronic announced that a defective tool used in themanufacturing process of the stoppers caused the leaking problem.
Medtronic notified its customers that a leak in the reservoir could cause a serious health risk. The pump would deliver less than the proper amount of insulin if the reservoir leaked. Additionally, the pump’s alarm would not sound if the leak led to a blockage.
Only a month prior, Medtronic notified customers about a concern with fluids building up in the tubing connectors of the Paradigm Insulin Pump. Medtronic cautioned that spilling of insulin on the pump could block a vent which would prevent the pump from priming. Blocked vents would prevent the pump from delivering the proper amount of insulin to the body. That could lead to hyperglycemia or hypoglycemia, depending on the quantity of insulin the pump provided. Either condition is potentially fatal to a diabetic. Additionally, a person could lose consciousness from becoming hyperglycemic or hypoglycemic.
In 2013, a New Jersey man died after falling into a diabetic coma. The estate of the deceased filed a wrongful death lawsuit against Medtronic claiming that the company was strictly liable for the damages it caused by its defective design, manufacturing, and testing process of its MiniMed Paradigm insulin pumps. The family of the diabetic patient said that the pump’s alarm failed to warn the patient of the problems happening with the pump when it delivered the wrong dosage of insulin. Medtronic designed the pump to monitor glucose levels constantly and alert the patient to the possibility of high or low bloodsugar.
The family of the deceased found the man in horrible circumstances. They discovered him covered in urine in his bed. He was unresponsive and unconscious at the time they found him. The man was in a coma and died several weeks later.
This tragedy comes on the heels of a 2009 incident where a diabetic patient using the MiniMed system died from hypoglycemic shock. Once again, Medtronic’s device failed to operate as designed. The FDA issued a Class 1 recall of the device,and within days the woman died.
Call Parker Waichman LLP today to schedule a free, no-obligation consultation to discuss your claim, or if more convenient, you can fill out our online form. Do not delay. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) and speak with one of our Medtronic Insulin Pump lawyers about your rights.
