Device product
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Z-1282-2019
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 81656
- Status
- Terminated
- Classification
- Class II
- Quantity
- Approximately 9,328 registered users
- Official record key
device-enforcement:Z-1282-2019
Official wording
Reason: The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
Code information: UDI - (01)00643169693142(10)
Distribution pattern: Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.
Derived failure modes
-
Unknown
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.