Medtronic is recalling about 322,000 MiniMed 600 Series diabetic insulin pumps due to a defect linked to thousands of patient injuries and one death, the Food and Drug Administration (FDA) cautioned in a safety communication. The issue is identified as a Class I recall, the most serious type of recall reserved for situations in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
Insulin pumps are small devices that deliver insulin to diabetic patients to help them reach desired blood glucose levels in order to manage their chronic disease. Certain Medtronic MiniMed 600 Series insulin pumps were found to deliver incorrect insulin dosing due to a missing or broken retainer ring, which helps lock the insulin cartridge in place in the pump’s reservoir compartment.
If the insulin cartridge is not properly locked in place, it can interfere with the delivery of insulin, which could cause patients to become hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar). Signs of hypoglycemia include dizziness, confusion and weakness. Severe hyperglycemia can lead to loss of consciousness, seizures, or death. The FDA has received 26,421 complaints about the malfunction including 2,175 injuries and one death.
Affected devices include the Model 630G, for patients 16 years of age and older, and the Model 670G, indicated for patients 14 years and older. Patients with these devices who have questions should talk with their doctors.
Medtronic sent letters to patients with affected insulin pumps encouraging them to examine the trainer ring used in their pumps. If the reservoir does not lock into the pump properly, or if the ring is loose, damaged, or missing, the FDA advises patients to stop using the insulin pump and instead use manual insulin injections per their doctor’s recommendations. Patients with affected devices who do not see issues with the reservoir lock can continue to use the pumps, but they should remember to follow the device instructions and routinely examine their pump retainer ring.
Patients with recalled insulin pumps can contact Medtronic for a replacement if there are any issues with the reservoir properly locking into place. Medtronic Technical Support can be reached at 877-585-0166.
In June, the FDA warned of the possibility of cybersecurity risks that Medtronic’s MiniMed Paradigm models. Someone nearby could connect wirelessly and potentially hack into the devices, the agency warned.
Any adverse events related to this recall should be reported to the FDA MedWatch program.