Official recall record

Continuous glucose monitoring smart device software applications

What the authority reported

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 to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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