FDA Alerts Users About Diabetes Device Safety Concerns

The US Food and Drug Administration (FDA) has issued a warning concerning safety issues affecting smartphone-connected diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps, and automated insulin delivery systems. The FDA has received reports indicating that, in some cases, alerts are not being sent or heard as expected, even when users believe they have properly configured their settings.

This failure to receive alerts could have serious consequences, including severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, and in extreme instances, death. Courtney Lias, Director of the Office of In Vitro Diagnostic Devices, FDA, urges users to monitor their alert settings to ensure that alerts are functioning as intended. She adds that even when alerts are properly configured, certain hardware or software changes can interfere with the device’s performance, potentially leading to harmful situations if the alerts go unnoticed.

The FDA has identified several factors that can interfere with the proper functioning of alert systems. Software configuration issues, such as incorrect notification permissions, the activation of “Do Not Disturb” or “Focus” modes, or apps being “disconnected” after periods of inactivity, can prevent alerts from being received. Connecting new hardware can also alter the volume of alerts or block them entirely. Updates to smartphone operating systems that are incompatible with the medical device’s app can also disrupt alert delivery.

To reduce the risk of missed alerts, the FDA urges users to follow the manufacturer’s instructions carefully when installing, configuring, or updating the device’s mobile app. Users should also disable automatic updates to their smartphone operating system and avoid updating it until they confirm the medical device app is compatible with the new version. After any updates to the smartphone’s operating system or the addition of new accessories, such as wireless headphones, users are encouraged to review their alert settings and closely monitor the app to ensure alerts are functioning properly. 

Additionally, users should check their alert configurations at least once a month to ensure they are set up as intended.