MiniMed Insulin Pump Injuries

Type 1 diabetes is a chronic illness where the pancreas produces insufficient insulin to metabolize blood glucose in the bloodstream. Without daily injections of insulin, type 1 diabetics would not be able to survive. They walk a fine line as they must continually offset the blood glucose derived from the foods that they eat with the proper amount of insulin they inject to maintain a healthy balance in the body. Insulin pumps mimic the pancreas by constantly monitoring blood glucose levels and infusing just the right amount of insulin. The American Diabetes Association says they offer many advantages to diabetics and simplify diabetes management.

History

• Pacesetter Systems introduced their first insulin pump, the MiniMed 502, in 1983. They continued to make improvements to the system, including a flexible cannula to replace the rigid metal needle, a programmable menu, smaller size and insulin-friendly tubing. The Space Technology Hall of Fame inducted MiniMed into their Space Technology Hall of Fame in 1988 for applying NASA technology to their implantable insulin pump. They also spun off the business under the new name of Medtronic.

Recalls

• In July of 2009, the United States Food and Drug Administration announced that Medtronic had initiated a voluntary recall for a specific lot of infusion sets designed to work with the MiniMed Paradigm insulin pump. Infusion sets carry insulin from the insulin pump's reservoir to the patient through flexible tubing.

  Medtronic stated that approximately 2 percent, or 60,000 out of 3 million infusion sets from their Lot 8, were preventing the pump from regulating air pressure resulting in the delivery of too much or too little insulin. The defective infusion sets involved in the recall resulted in over 200 hospitalizations of diabetic users, but no deaths or permanent injuries were recorded.

Complications

• Too much insulin in the body results in a very dangerous condition called hypoglycemia which quickly leads to seizures, unconsciousness, coma and, in extreme or untreated cases, death. Too little insulin results in a condition called hyperglycemia which leads to stroke, blindness, blood clots, heart attacks kidney damage and potentially death. Diabetics are not always aware that their blood glucose levels are too high or too low, particularly if they rely on an insulin pump to monitor the levels and adjust the insulin for them.

FDA Warnings

• In June of 2009, the FDA sent a letter of warning to a manufacturing plant in Puerto Rico responsible for producing Medtronic's Synchromed II insulin pumps. Hospitalization for ketoacidosis due to defective pumps as well as insertion site infections had been reported.

Injuries

• Injuries not related to recalled products also happen. Approximately 13 deaths and 1,500 injuries have resulted from defective insulin pumps or improper use. Diabetic Sylvia Lane suffered a severe hypoglycemic episode in 2007. Her MiniMed pump continued to pump insulin into her as she lay alone in her apartment in a diabetic coma, simply because the factory default for a safety setting that would have prevented this was set to Off. Ms. Lane suffered severe, permanent brain damage from the incident. In 2006, 27-year old Steven Kreuger's MiniMed Paradigm insulin pump malfunctioned during the night, delivering a fatal dose of insulin. At least three other deaths and many cases of severe hypoglycemia have also been reported due to the MiniMed Paradigm insulin pump.