Public advisory

Warning: continuous glucose monitor safety alerts on smart devices, such as smartphones or smartwatches, may not work as expected

Last updated

Summary

Product
Continuous glucose monitoring smart device software applications
Issue
Medical devices - Inaccurate test or measurement results
What to do

Check your alert settings and refer to your device's manual to ensure the alerts are working as expected.

Distribution
National
Online
Alberta
British Columbia
Manitoba
New Brunswick
Newfoundland and Labrador
Northwest Territories
Nova Scotia
Nunavut
Ontario
Prince Edward Island
Quebec
Saskatchewan
Yukon

Affected products

  • Medical device
    • Haematology

Issue

Some people who use continuous glucose monitors have reported not receiving or hearing safety alerts from their smart devices, such as their smartphone or their smartwatch. If you miss a safety alert, you may fail to treat your low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), which could cause serious health issues requiring medical treatment, such as severely high or low blood sugar, loss of consciousness, seizure, coma and death.

Check your alert settings and refer to your device’s manual to ensure safety alerts are working as expected.

The safety alert volume may be affected by:

  • phone settings, such as sleep mode, focus mode, or do not disturb mode;
  • connections with other hardware that can change the default volume of alerts, such as Bluetooth, wireless earphones or car audio; and
  • operating system updates, battery saving features, and “deep sleep” mode (caused when the user does not use the device for long periods of time) can also cause malfunctions.

This issue only affects safety alerts from smart devices such as a smartphones; it does not affect other parts of your glucose monitor.

Health Canada will continue to work with the manufacturers of diabetes device apps to identify and reduce the risks of safety alerts being unintentionally silenced.

What you should do

  • If you feel unwell, check your glucose levels using your continuous glucose monitor or an alternative method, and seek medical attention if necessary.
  • Actively monitor your glucose levels until you have determined whether the app is alerting you properly.
  • Review the instructions provided with your continuous glucose monitor when installing, setting up, and updating glucose monitoring apps on your smart device.
  • Check your alert settings and volume, and refer to your device’s manual to ensure the safety alerts are working as expected with all of your smart device settings (including do not disturb, focus or sleep modes).
  • If you notice an issue with your alerts, contact the manufacturer for help troubleshooting your smart device settings.
  • Report any issues with your diabetes monitoring devices to Health Canada.

Additional information

Background

Continuous glucose monitoring devices may have an app on a smartphone, smartwatch or tablet to receive information and alerts instead of, or in addition to, a dedicated display device.

These apps provide people with diabetes with alerts, data tracking, and information on diabetes management, and may allow them to share alerts with caregivers or other contacts.

Smart device features can also affect apps that allow friends, family, caregivers, or other contacts to receive notifications when the person with diabetes has high or low blood sugar.

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Medical devices
Companies
Published by
Health Canada
Audience
General public
Health professionals
Distribution
National
Online
Alberta
British Columbia
Manitoba
New Brunswick
Newfoundland and Labrador
Northwest Territories
Nova Scotia
Nunavut
Ontario
Prince Edward Island
Quebec
Saskatchewan
Yukon
Identification number
RA-77131
Media and public enquiries

Media Enquiries (Également disponible en français)

Health Canada

613-957-2983

media@hc-sc.gc.ca

Public Enquiries

613-957-2991

1-866 225-0709

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