| Reason for the Action |
If an incompatible smart device or operating system is being used, a reliable communication between the insulin pump and the CamAPS FX app cannot be guaranteed. When they are first released, the latest Android operating system (OS) or Apple iOS update may not be compatible with the app and/or insulin pump.
The Instructions for Use (IFU) did not provide adequate clarity on smart device and operating system (OS) compatibility.
To address this, the “Compatible Smart Devices and Operating Systems” section of “Supported Devices”, in Chapter 11 of the IFU has been updated to direct users to the most up-to-date compatibility information on Ypsomed’s website which emphasises that both the smart device and OS must be supported by CamAPS FX and the connected glucose monitor.
Use of unsupported devices or OS versions may lead to app unavailability or reduced responsiveness. In such cases, the system defaults to delivering the pump’s pre-set basal rate, which may increase the risk of hypo- or hyperglycaemia. |