Missing Safety Alerts For Smartphone-Compatible Diabetes Devices

The Health Sciences Authority (HSA) would like to alert patients and caregivers to a potential safety issue with diabetes devices that use smartphones for critical alerts. These devices include continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems. Overseas incidents have been reported where alerts were not delivered or heard, potentially leading to patient harm, such as severe hypoglycemia (low blood sugar), severe hyperglycemia (high blood sugar), diabetic ketoacidosis, and death. HSA has not received any reports locally. 

Conditions Preventing the Delivery of Alerts on User’s Smartphone

1. Smartphone settings:

• Disabled application notification permissions,

• System-wide “do not disturb” or “focus mode” settings, and

• Applications placed in “deep sleep” by the system after an extended period of non-use, may prevent alerts from being issued.

2. Hardware changes:

• Connecting to wireless earphones or car audio systems can change the alert volume or prevent alert delivery.

3. Software conflicts:

• Operating system (OS) updates not supported by the mobile medical application.

Recommendations for Patients and Caregivers

1. Verify that your mobile application is configured according to manufacturer’s instructions. 

2. Contact your device’s technical support for assistance if application alerts are not working as expected. 

These issues may also affect other health-related mobile applications beyond the scope of diabetes management. 

You may also refer to related advisory published by the US FDA

(FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes | FDA)

Reporting of Incidences

Patients, caregivers and healthcare professionals should report any adverse events (AE) and/or suspected adverse events to the Medical Devices Cluster, Health Products Regulation Group, HSA at Tel: 6866 1048, or report online using the e-form below. 

AE Reporting e-Form