The FDA today issued a safety communication relating to certain diabetes devices that connect to smartphones.
Our sister site, Drug Delivery Business News, reports today that the FDA received medical device reports in which users reported failed delivery of alerts or failure to hear alerts from their smartphones that connect to diabetes devices. In these cases, the users thought they configured the alerts for delivery. In some cases, missing alerts may contribute to serious harm.
Devices like continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems can use smartphones to deliver alerts. Users can configure alert settings through applications on their phone.
The agency identified certain hardware and software changes that may lead to failed alert delivery. 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, may contribute.
Get the full story at our sister site, Drug Delivery Business News.
