Devices

Diabetes Device Smartphone Alerts Malfunctioning: FDA

FDA has issued a safety alert on certain diabetes devices (e.g., continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems) that rely on a smartphone to deliver critical safety alerts. Smartphone users with diabetes-related apps on their phones can configure alert settings to customize which alerts to receive, how often and how and where the alerts are delivered.

Recently, the agency says it has begun receiving medical device reports in which “users report these alerts are not being delivered or not being heard, in cases where the users thought they had configured the alerts to be delivered. In some cases, missing these alerts may have contributed to serious harm, including severe hypoglycemia (low blood sugar), severe hyperglycemia (high blood sugar), diabetic ketoacidosis (when the body does not have enough insulin to use blood sugar for energy) and death.”

The agency says the following hardware and software changes, updates and configurations may lead to critical alerts not being received as expected:

software configuration issues, such as app notification permissions, using “do not disturb” or “focus mode” or the app entering “deep sleep” after a period of not being used;
connecting new hardware to the smartphone, such as connecting to car audio or using wireless earphones, that can change the default volume of alerts or prevent delivery of alerts; and
smartphone operating system updates that are not supported by the medical device application.

The alert also provides recommendations for device users to help make sure the diabetes alerts work.

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