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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medtronic MiniMed 600 Series Insulin Pump System - Potential Cybersecurity Risk

Today, the U.S. Food and Drug Administration (FDA) is alerting medical device users about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System (for example: MiniMed 630G and MiniMed 670G).

There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. A nearby person other than you or your care partner may be able to gain access to the pump while the pump is being paired with other system components. If unauthorized access occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin.

The FDA is working with Medtronic to identify, communicate, and prevent adverse events related to this cybersecurity vulnerability. The FDA will keep the public informed if significant new information becomes available

Questions?

If you have questions about the Medtronic MiniMed Insulin Pump, contact the Division of Industry and Consumer Education.