|
Potential to Miss Critical Safety Alerts for Smartphone-Compatible Diabetes Devices
The FDA is alerting patients who use diabetes devices, as well as their caregivers and health care providers, of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. These devices allow users to configure alert settings, such as which alerts to receive, how often, and how the alerts are delivered (such as audible, vibration, or text only). If a user’s smartphone is not configured correctly, critical safety alerts that the user expects to receive may be missed.
This safety communication provides:
- Recommendations for patients and their caregivers who use smartphone-compatible diabetes devices.
- Recommendations for health care providers.
- Background on the safety concern and the FDA’s actions to address the issue.
- Instructions for reporting problems with your smartphone-compatible diabetes devices to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
|
