FDA Warns About Cybersecurity Concerns with Some Medtronic Insulin Pumps

Miss. shows the Medtronic Paradigm REAL-Time Revel insulin pump of Polly Varnado's daughter. Medical device manufacturers and experts say insulin pumps are safe. But an AP investigation found that insulin

Miss. shows the Medtronic Paradigm REAL-Time Revel insulin pump of Polly Varnado's daughter. Medical device manufacturers and experts say insulin pumps are safe. But an AP investigation found that insulin

The medical device maker is recalling almost a dozen Medtronic MiniMed models based on concerns that outside individuals could connect to the pumps wirelessly and control insulin delivery, according to the FDA.

If a patient is using one of the pumps, they could be at risk of "an unauthorized person with special technical skills and equipment" connecting to the device and changing how much insulin is delivered, according to a letter sent to patients and health-care providers and posted on Medtronic's website.

The FDA said it's not aware of anyone actually doing this, but if the issue is not addressed, it said the risk to diabetes patients is "significant".

Medtronic is recommending that diabetics who use the pump take several precautions, including keeping the pump and devices connected to the pump "within your control at all times".

While health professionals have warned that wireless medical devices - like all devices that connect to the internet - could possibly be hacked, it's largely a theoretical risk so far.

"The FDA urges manufacturers everywhere to remain vigilant about their medical products - to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them", said the agency in its latest alert.

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MiniMed 508 and Paradigm devices may be vulnerable to hacking. Because information to create these DIY systems is shared online, these devices could also be at risk, Zonszein said. "Patients outside the US will receive a notification letter with instructions based on the country where they live", ICS-CERT noted.

Blood glucose meters for diabetes topped the list of device malfunction and incidents in the FDA's once-hidden "alternative summary" reporting database, with 2.4 million reports over the past 2 decades.

Affected models include all versions o the MiniMed 508, MiniMed Paradigm 511, MiniMed Paradigm512/712, MiniMed Paradigm 515/715, MiniMed Paradigm 522/722 and MiniMed Paradigm 522K/722K.

A spokesperson for Medtronic Canada declined to say how many customers were affected but said the company has notified anyone who purchased the pumps in the past and may not have already upgraded. "As technologies evolve, we will continue to collaborate with industry researchers and regulators to improve device security approaches and develop high-quality therapies that positively impact lives".

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