On September 20, 2022, the United State Food and Drug Administration issued a public warning to people who have diabetes about using the Medtronic MiniMed 630G or MiniMed 670G insulin pumps. The warning states that these medical devices carry a cybersecurity risk. The agency’s press release also states that the MiniMed 600 series insulin pumps contain certain wireless components, such as the continuous glucose monitoring transmitter, pump itself, CareLink USB device, and blood glucose meter, and these wireless components could allow unauthorized access to the system leading to injuries or death.
According to Medtronic, unauthorized access might compromise the insulin pump’s communication protocol causing the device to deliver too little or too much insulin. This could occur should an unauthorized person who is close to the insulin pump gain access to a user’s insulin pump as its being paired with the system’s components. The cyber hack cannot be performed over the Internet.
Medtronic sent its Urgent Medical Device Correction to notify users of this serious cybersecurity risk. The company’s letter includes steps that can be taken to avoid unauthorized access. This is the second time in four years that cybersecurity vulnerabilities have been linked to Medtronic MiniMed insulin pumps. Medtronic has already issued recalls for its MiniMed Paradigm series insulin pumps and MiniMed 508 insulin pumps in 2019.
According to the news alert, neither the FDA nor Medtronic has received any adverse incident reports related to the cybersecurity vulnerability. Medtronic and the FDA are working to identify, communicate, and avoid adverse events connected to any cybersecurity vulnerabilities.
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