Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks | FDA

Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks | FDA

A MedWatch Safety Alert was just added to the FDA Medical Device Recalls webpage.  TOPIC: MiniMed Insulin Pumps by Medtronic: Class I Recall - Due to Potential Cybersecurity Risks AUDIENCE: Patient, Endocrinology, Health Professional, Risk Manager BACKGROUND: 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. ISSUE: Medtronic is recalling the specified 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. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks. The affected products are the MiniMed Model 500 Remote Control and 503 Remote Transmitter (MMT-500 and MMT-503). RECOMMENDATION: On June 27, 2019, Medtronic instructed patients 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 patients 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. Patients should seek 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 their insulin pump settings or insulin delivery changed unexpectedly. Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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