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The FDA sent out the warning about the smartphone notification issues in a news release on Wednesday, Feb. 5. The agency said it has received reports of users missing alerts they believed were properly configured, leading to dangerous issues like diabetic ketoacidosis and deaths.
Many of these smartphone-compatible devices allow users to customize how they receive alerts, choosing options like audible notifications, vibrations, or text-only messages, but sometimes the alerts aren't delivered or noticed.
"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," said Courtney Lias, director of the FDA's Office of In Vitro Diagnostic Products. "However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected."
The FDA identified several potential issues that could prevent alerts from functioning properly. Software settings such as notification permissions, "do not disturb" modes, or apps going into "deep sleep" after inactivity may interfere with alert delivery.
Connecting Bluetooth accessories like car audio systems or wireless headphones can alter default volume settings or block alerts altogether. Phone operating system updates may also create compatibility issues with medical device apps, causing alerts to fail.
To reduce risk, the FDA advises patients to carefully follow manufacturer instructions when installing, setting up, or updating mobile medical apps. Patients should turn off automatic smartphone updates and confirm app compatibility before updating their operating system.
After installing updates or connecting new accessories, users should recheck their alert settings and monitor notifications to ensure they are received and audible. The FDA recommends reviewing alert settings at least once a month and contacting the medical device manufacturer if alerts are not working properly.
The FDA also said it's working with manufacturers to enhance testing of smartphone alert settings and ensure users receive timely guidance on necessary updates or adjustments.
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