| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00954-1 |
| Product Name/Description |
CamAPS FX and mylife CamAPS
Product code: 64648
App version 1.4(174) and earlier versions
ARTG 390330
(Ypsomed Australia Pty Ltd - Ambulatory insulin infusion pump software patient-dosing) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
A double bolus was administered via the CamAPS FX App in a user in Germany.
The user was administered an 8.1-unit mealtime bolus due to unexpected behaviour of the operating system,
The incident was caused by the countdown to bolus delivery starting twice by the operating system.
This error is extremely rare but may lead to repeated delivery of a standard insulin bolus when initiated from the app, which can result in hypoglycaemia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users must check the version of the mylife CamAPS FX by clicking on App main menu>About>(UI)1.4(xxx))
If version 1.4(175) is already installed, no action is required.
For users on version 1.4(173) or 1.4(174), Update to the new mylife CamAPS FX version 1.4(175), available on Google play, is needed.
All earlier versions will be discontinued on 15th December 2023.
This action has been closed out on 06/02/2024 |
| Contact Information |
1800 447 042 - Ypsomed Australia |