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Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
The FDA is aware that Dexcom has sent all affected customers an Urgent Medical Device Correction Notification for the Dexcom G7 Continuous Glucose Monitoring (CGM) App (for Android, iOS, and watchOS devices) and the Dexcom ONE+ CGM App (for Android and iOS devices). The correction is for a software design error that leads to a missed “Sensor Failed” alert when the sensor’s transmitter encounters a hardware/firmware failure.
The failure to alert the user of a failed transmitter may result in the user being unaware of extended periods of missed glucose data, notifications, alerts and alarms, which may result in a delay in treatment of prolonged episodes of severe hypoglycemia or hyperglycemia. The use of affected product may cause serious adverse health consequences, including hypo/hyperglycemia and death.
There have been no reported injuries or deaths related to this issue.
This recall involves correcting certain devices through a software update and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Dexcom Technical Support at 1-844-478-1600. For global customers, please visit Dexcom.com to find local Technical Support contact information.
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