What to Do if You Have a Recalled Medtronic Device
Medtronic has recently recalled the following types of insulin pumps, which may put diabetic patients at risk of receiving too much or too little insulin and could have potentially fatal results:
MiniMed 600 Series Insulin Pumps
Model 630G (MMT-1715) - all lots before October 2019
Model 670G (MMT-1780) - all lots before August 2019
Model 630G - September 2016 to October 2019
Model 670G - June 2017 to August 2019
How Do Defective Medtronic Devices Harm Individuals?
According to the Centers for Disease Control and Prevention, diabetes is a chronic (long-lasting) health condition that affects how your body turns food into energy. Most of the food you eat is broken down into sugar (also called glucose) and released into your bloodstream. When your blood sugar goes up, it signals your pancreas to release insulin. Insulin acts like a key to let the blood sugar into your body’s cells for use as energy. When the pump malfunctions, it can cause too much insulin or not enough insulin to enter your body. This can lead to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), resulting in hospitalizations, comas, or even death. The FDA classified the recall as a Class 1 recall and determined that there was a reasonable probability that the use of, or exposure to, the Medtronic pumps manufactured with the clear retainer ring would cause serious adverse health consequences, including:
Severe hypoglycemia, which can result in loss of consciousness or seizure;
Severe hypoglycemia, which can result in diabetic ketoacidosis or hyperosmolar hyperglycemic state, and metabolic abnormalities; or
The FDA further determined that Medtronic:
Failed to adequately implement procedures for corrective and preventive action;
Failed to adequately analyze all sources of quality data;
Failed to identify actions needed to correct nonconforming product; and
Did not appropriately verify or validate the change to the pumps to ensure corrective and preventive actions taken were effective and did not adversely affect the finished device.