Critical safety alerts from smartphone-connected diabetes devices may fail to reach patients due to device configurations and updates, potentially leading to severe complications including death, the FDA warned.
The agency received reports of missed alerts from continuous glucose monitors, insulin pumps, and automated insulin dosing systems that interface with smartphones. These incidents have resulted in severe hypoglycemia, hyperglycemia, and diabetic ketoacidosis.
"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," said Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA's Center for Devices and Radiological Health.
The FDA identified the following hardware and software changes, updates, and configurations that may lead to missed alerts:
- Software configuration issues, including app notification permissions and "do not disturb" settings
- Hardware changes affecting alert delivery, such as connection to car audio or wireless earphones
- Smartphone operating system updates incompatible with medical device applications
The FDA's recommendations include:
- Deferring automatic operating system updates until confirming app compatibility
- Verifying alert configurations monthly
- Testing alert functionality after system updates or adding new accessories
- Contacting device technical support for alert delivery issues
The agency is collaborating with device manufacturers to enhance smartphone alert configuration evaluation and expedite communication of recommended setting updates to users.
Reference: FDA Safety Communication: Potential to Miss Critical Safety Alerts for Smartphone-Compatible Diabetes Devices.