FDA Issues Safety Communication about Potential Cybersecurity Risks in Certain Medtronic MiniMed Insulin Pumps

PUBLISHED: Jun 28, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued a safety communication warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks.

Medtronic cannot update the MiniMed™ 508 and Paradigm™ insulin pump models to address these potential cybersecurity risks. As a result, the FDA recommends patients replace affected pumps with models that are better equipped to protect them from these risks. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.

See the safety communication for a complete list of MiniMed pumps being recalled by Medtronic; the manufacturer is providing alternative insulin pumps to patients.

Health care providers are encouraged to familiarize themselves with the manufacturers recommendations for patients and caregivers listed in the safety communication; these recommendations are also summarized below.

Recommendations:

  • Patients/caregivers should check to see if the model and software version of thier insulin pump is affected. Read the Medtronic Patient Letter to learn how to identify your pump’s software version. If you live outside the United States, Medtronic will send you a notification letter with instructions based on the country where you live.
  • Talk to your health care provider about a prescription to switch to a model with more cybersecurity protection.
  • If you have questions about replacing your pump, call Medtronic at 1-866-222-2584 or go to Medtronic’s website..

To minimize the potential risk of a cybersecurity attack while you are waiting for a replacement pump:

  • Keep your insulin pump and the devices that are connected to your pump within your control at all times whenever possible.
  • Do not share your pump serial number.
  • Be attentive to pump notifications, alarms, and alerts.
  • Monitor your blood glucose levels closely and act appropriately.
  • Immediately cancel any unintended boluses.
  • Connect your Medtronic insulin pump to other Medtronic devices and software only.
  • Disconnect the USB device from your computer when you are not using it to download data from your pump.

Get medical help right away if you:

  • 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.

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