FDA Issues Safety Alert on Smartphone-Compatible Diabetes Devices Over Missed Critical Alerts

The agency has received multiple reports indicating that users may not be receiving or hearing these alerts, potentially leading to serious health complications, including death.

The US Food and Drug Administration (FDA) has issued a safety communication warning patients about potential risks associated with smartphone-compatible diabetes devices.

These devices include continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, which rely on smartphones to deliver critical safety alerts.

The agency has received multiple reports indicating that users may not be receiving or hearing these alerts, potentially leading to serious health complications, including death.

Potential Risks from Missed Alerts

According to the FDA, users can customize alert settings on their smartphones to control which notifications they receive, how frequently they appear, and how they are delivered—whether through audible sounds, vibrations, or text-only alerts.

However, the FDA has received medical device reports indicating that some users are not receiving these critical alerts as expected.

In certain cases, missed alerts have contributed to severe health events such as hypoglycemia (dangerously low blood sugar), hyperglycemia (high blood sugar), diabetic ketoacidosis (a serious condition where the body lacks sufficient insulin to use glucose for energy), and even fatalities.

Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, emphasized the importance of vigilance when using these devices.

“Modern medical devices that connect to smartphones offer users the convenience of personalized alerts. However, it is crucial for users to monitor these devices and ensure they continue to receive critical alerts as configured,” she said.

Lias added that even when settings are correct, changes in hardware or software could disrupt the device’s expected operation, posing serious health risks if left unnoticed.

Factors Contributing to Missed Alerts

The FDA has identified several factors that may contribute to missed alerts.

These include software configuration issues, such as incorrect app notification permissions, activation of “Do Not Disturb” or “Focus Mode,” or the app entering “deep sleep” after periods of inactivity.

Additionally, connecting new hardware to smartphones, like car audio systems or wireless earphones, can alter default volume settings or prevent alerts from being delivered.

Operating system updates on smartphones that are not compatible with the diabetes device applications have also been flagged as a potential risk.

FDA Recommendations for Users

To address these concerns, the FDA has provided recommendations for users of smartphone-compatible diabetes devices. Patients are advised to carefully follow manufacturer instructions when installing, setting up, or updating mobile medical applications on their smartphones.

It is also recommended that automatic operating system updates be turned off to prevent unintended disruptions.

Before updating the phone’s operating system, users should verify that the diabetes device application is compatible with the new version.

After any updates or when adding new accessories, such as wireless headphones, patients should check their alert settings and monitor the app to ensure alerts are being received and can be heard as expected.

Regular monthly checks of smartphone alert configurations are also advised to ensure the settings remain correct.

If users find that alerts are not being received or heard as expected, they are encouraged to contact the medical device manufacturer’s technical support for assistance.

Additionally, the FDA urges patients to report any problems with their diabetes devices to the agency.

These reports help the FDA monitor device performance and address emerging safety concerns promptly.

Collaboration with Manufacturers

The FDA is actively collaborating with medical device manufacturers to address these issues.

The agency is working to ensure that smartphone alert configurations are rigorously evaluated before devices reach patients.

In addition, the FDA is urging manufacturers to continuously test smartphone and mobile app settings that could affect safety alerts and to communicate any updates or changes promptly to users.

The FDA’s safety communication, titled “Potential to Miss Critical Safety Alerts for Smartphone-Compatible Diabetes Devices,” reflects the agency’s commitment to safeguarding patients relying on advanced medical technologies.

By ensuring robust alert systems and clear communication from manufacturers, the FDA aims to reduce the risks posed by missed or undelivered alerts.

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