The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts.
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 FDA received medical device reports in which users reported failed delivery of alerts or failure to hear alerts. In these cases, the users thought they configured the alerts for delivery. In some cases, missing alerts may contribute to serious harm. That could include 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.
According to the FDA notice, 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.
The FDA also said connecting new hardware to the phone can change the default volume of alerts or prevent alert delivery. That could include connecting to car audio and using wireless earphones. Additionally, some smartphone operating system updates aren’t supported by the medical device application.
Instructions from the FDA for device users
In its safety communication, the FDA told device users to carefully follow instructions provided by device manufacturers. They should also turn off automatic operating system updates to their phone and delay updates until confirming compatibility with the diabetes device app.
After updating the phone or adding a new accessory, users should confirm alert settings and carefully monitor the device app. At least once a month, the FDA says users should check their smartphone alert configuration.
If users fail to receive alerts as expected, they should call the technical support number for the medical device, the FDA said. Users should also report any problems with the diabetes device to the agency.
The FDA said it continues to work with diabetes-related device manufacturers to carefully evaluate smartphone alert configurations. It also wants to ensure settings that may impact safety alerts are continuously tested and any updates to recommended configurations are communicated quickly and clearly to users.
“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. “Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
