| TGA Action ID |
RC-2026-RN-00275-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
YpsoPump Orbit Micro 2.0 Infusion Sets
Product codes: MYOYP2-1851 & MYOYP2-2451
Batch Numbers: 261090 & 261091 |
| ARTG Number |
281787 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In June 2024, mylife Diabetes Care Australia Pty Ltd (Formerly Ypsomed Australia Pty Ltd) executed a Product Alert (RC-2024-RN-00444-1) for YpsoPump Orbit Micro 2.0 which included recommendations for patient management in case of skin irritation. Through post market surveillance (PMS), an increased frequency of reported skin irritation complaints were identified with the product.
The root cause analysis concluded the skin irritations were caused through the design of the base and the welding structure which generated a rough surface and placed mechanical stress to the skin during the 48-hour wear time.
The manufacturing process for Orbit Micro 2.0 has been updated. This change smooths the skin-contact surface of the infusion set. User testing demonstrated a significant reduction in mechanically induced skin irritation. |
| Instructions for Customers/Users |
- The updated infusion sets will be introduced via the existing wholesaler & pharmacy supply channels and are available from April 2026 onwards.
- Healthcare professionals managing mylife Loop users that use Orbit Micro 2 Infusion sets are to ensure users are made aware of the update.
- If users have experienced skin irritation with the previous design, contact Customer Service for replacement stock of the updated infusion set. |
| Action Commencement Date |
24/04/2026 |
| Responsible Entity |
|
| Contact Information |
1800 447 042 - mylife Diabetes Care Customer Service |