WASHINGTON — The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic are vulnerable to cyberattacks, meaning hackers could tamper with device access and insulin delivery.
The agency issued a cybersecurity risk alert for the Medtronic MiniMed 600 Series insulin pump system, which has several components including an insulin pump and a blood glucose meter that communicate wirelessly, Reuters reported.
"The FDA is alerting medical device users about a cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System." https://t.co/lrsmuJeKTq— Leigh Turner (@LeighGTurner) September 20, 2022
To date, Medtronic has not fielded any reports linked to the cybersecurity threat, but the FDA alert indicated that unauthorized persons may be able to gain access to a pump while it pairs with other system components.
According to Reuters, the affected insulin pumps are sold through Medtronic’s diabetes segment, which generated more than $2.4 billion in sales in 2021 and accounted for 8% of the company’s total revenue.
The FDA stated it is working closelywith Medtronic to identify, communicate and prevent adverse events related to the cybersecurity risk.
Meanwhile, Medtronic also warned users about the risks and made recommendations including “asking them to permanently turn off the ‘Remote Bolus’ feature on the pump, not share device’s serial number with unauthorized personnel or conduct any connection linking of devices in a public place,” Reuters reported.
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