Photo Credit: Mohd Izzuan
The FDA is urging patients with smartphone-compatible diabetes devices to check their phone configurations to ensure all safety alerts are being received. The FDA notice concerns continuous glucose monitors, insulin pumps, and automated insulin dosing systems that rely on a smartphone to deliver critical safety alerts. The agency has received reports that patients are not receiving or hearing the alerts even though they thought the alerts had been configured for delivery. In a safety communication, the FDA suggested turning off automatic operating system (OS) updates and not updating the smartphone’s OS until confirming the diabetes device app is compatible with the new version; after updating the OS or adding a new accessory, carefully monitoring the device app to ensure alerts are received and heard as expected; checking that alerts are configured as expected at least once per month; and, if alerts are not being received as expected, calling the technical support number for the medical device for assistance.