Medtronic is recalling MiniMed Model 500 Remote Control and 503 Remote Transmitter (MMT-500 and MMT-503) insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. This person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death.
People who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump includes a remote controller which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.
Who May be Affected
Any person who uses an affected Medtronic MiniMed insulin pump
Healthcare providers who treat people with diabetes using the affected MiniMed insulin pumps
On June 27, 2019 Medtronic notified affected customers. The notice instructed customers to talk to their health care provider about a prescription to switch to a model with more cybersecurity protection.
To minimize the potential risk of a cybersecurity attack while waiting for a replacement pump, Medtronic advised customers to:
- Keep their insulin pump and the devices that are connected to their pump within their control at all times whenever possible.
- Do not share their pump serial number.
- Be attentive to pump notifications, alarms, and alerts.
- Monitor their blood glucose levels closely and act appropriately.
- Immediately cancel any unintended boluses.
- Connect their Medtronic insulin pump to other Medtronic devices and software only.
- Disconnect the USB device from their computer when they are not using it to download data from their pump.
Get medical help right away if they:
- Have symptoms of severe hypoglycemia (such as excessive sweating, feeling very tired, dizzy and weak, being pale, and a sudden feeling of hunger).
- Have symptoms of diabetic ketoacidosis (such as excessive thirst, frequent urination, nausea and vomiting, feeling very tired and weak, shortness of breath).
- Think your insulin pump settings or insulin delivery changed unexpectedly.
Customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 800-646-4633.