FDA Alert – Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing
The Medtronic Insulin Pump Recall affects people with diabetes.
Diabetes is a serious medical condition. It requires close attention to one’s blood sugar levels. Failure to keep blood sugar levels in a safe range over time can lead to blindness, kidney failure, heart disease, and other serious conditions.
There are different types of diabetes. People with Type I do not produce insulin. Insulin is a hormone that helps the body use sugar. People with Type I diabetes have to supplement insulin because their bodies do not make it naturally. By comparison, people with Type II diabetes are able to produce insulin within their bodies, but their bodies have trouble using it. The Medtronic Insulin Pump Recall affects people managing their diabetes with insulin pumps.
Diabetes in America and Insulin Pumps
According to the American Diabetes Association, 30.3 million Americans (9.4% of the population) had diabetes in 2015. One form of treatment available in the United States is self injection. An insulin pump is an alternative to self injection. These computerized devices deliver insulin throughout the day to help to manage blood sugar levels.
Insulin pumps are popular in America. FDA regulates them as medical devices. From FDA, “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” As part of its mission, FDA announces recalls of medical devices.
Medtronic Insulin Pump Recall
An FDA safety communication notes that Medtronic recalled its MiniMed Insulin Pumps due to incorrect insulin dosing. The FDA has identified this as a Class I recall. A Class I recall is the most serious kind. It means that use of these devices may cause serious injuries or death. This does not mean any patient should stop using the device. Patients should discuss this with their healthcare physicians.
The Medtronic Insulin Pump Recall concerns a missing or broken retainer ring. The ring helps lock the insulin cartridge in place in the pump’s reservoir compartment. More specifically, FDA writes that “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. 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.”
American news media reports the Medtronic Insulin Pump Recall. CNN reports that this recall follows injuries and one death reportedly due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday. FDA noted that the medical device company received a total of 26,421 complaints in which the device malfunctioned in this manner, and the firm is aware of 2,175 injuries and 1 death.
People Potentially Impacted by this Recall
FDA identified the following people who may be affected by the Medtronic Insulin Pump Recall :
- Any person with diabetes who uses an affected Medtronic MiniMed insulin pump
- Health care providers who treat people with diabetes using the affected MiniMed insulin pumps
FDA notes further that people with Type I diabetes may use the MiniMed insulin pump. This includes people over 16 years old who may use the Model 630G insulin pump. It also includes people over 14 years old who may use the Model 670G insulin pump.
The Medtronic Insulin Pump Recall involves over 300,000 products. FDA identifies the following products as part of this Medtronic Insulin Pump Recall:
- MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) – all lots before October 2019
- Model 670G (MMT-1780) – all lots before August 2019
- Distribution Dates:
- Model 630G – September 2016 to October 2019
- Model 670G – June 2017 to August 2019
- Devices Recalled in the U.S.: 322,005
- Date Initiated by Firm: November 21, 2019
What to Do
FDA reported that on November 21, 2019, Medtronic notified affected customers and advised them to:
- Examine the retainer ring of their pump.
- Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor’s recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
- Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.
The site direct customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166. Additionally, health care professionals and patients may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
Patients should speak with their healthcare professionals. If they were injured and seek legal redress, they may consult an attorney.
Medical Device Lawsuits
Attorneys bring medical device lawsuits when companies fail to address risks to patients. This can result from a failure to follow industry standards, including FDA regulations. This can happen when companies do not have good systems in place.
People hire attorneys to file lawsuits and bring product liability and/or negligence claims when medical devices fail. These are complicated cases with many potential barriers. Experience counts when pursuing such cases.