Hardware and software changes, updates, and configurations can result in undelivered critical safety alerts
By Stephanie Brown HealthDay Reporter
TUESDAY, Feb. 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration is urging all patients with smartphone-compatible diabetes devices to check their phone configurations to ensure all safety alerts are being received.
The FDA notice concerns continuous glucose monitors, insulin pumps, and automated insulin dosing systems that rely on a smartphone to deliver critical safety alerts. The agency has received reports that patients are not receiving or hearing the alerts even though they thought the alerts had been configured for delivery.
In a safety communication, the FDA offers several suggestions for users of the devices, including turning off automatic operating system (OS) updates and not updating the smartphone’s OS until confirming the diabetes device app is compatible with the new version; after updating the phone’s OS or adding a new accessory, carefully monitoring the medical device app to make sure alerts are received and can be heard as expected; checking that the smartphone alerts are configured as expected at least once a month; and, if alerts are not being received as expected from the mobile medical app, calling the technical support number for the medical device for assistance.
“Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected,” Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA Center for Devices and Radiological Health, said in an agency news release. “Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
The FDA is working with diabetes-related medical device manufacturers to ensure smartphone alert configurations of devices are carefully evaluated before patient use and that any updates to recommended configurations are communicated quickly and clearly to users.
Stay up to date on the latest in health — Click here to subscribe to our weekly newsletter!
Copyright © 2025 HealthDay. All rights reserved.
