People using YpsoPump Orbit Micro 2.0 infusion sets are being advised of a product update designed to improve comfort and reduce the likelihood of skin irritation. 

The update applies to YpsoPump Orbit Micro 2.0 infusion sets supplied in Australia since October 2023. The products are not being recalled and remain safe to use. 

The change follows routine post-market monitoring, which identified a higher frequency of reported skin irritation among some users. Skin irritation is recognised as a possible reaction when using infusion sets, and guidance recommended rotating infusion sites or considering alternative sets if irritation occurs. 

A detailed review found that the design of the Orbit Micro 2.0 infusion set base and its welding structure could create a slightly rough surface where the device contacts the skin. Over time, and with the need to replace the base every 48 hours, this may contribute to mechanical irritation of the skin. 

In response, the manufacturer, mylife Diabetes Care Australia, has updated the design and production process to create a smoother skin-contact surface. Testing has shown this refinement significantly reduces mechanically induced skin irritation, without changing the materials used in the product. 

The updated infusion sets are now being introduced through normal pharmacy and wholesale supply channels in Australia. No action is required for people currently using the device. 

Those using mylife Loop systems that rely on Orbit Micro 2.0 infusion sets should simply be aware of the update as new stock becomes available.  

Individuals who have experienced skin irritation with earlier versions may wish to speak with their healthcare team or contact mylife Diabetes Care Australia customer support on 1800 447 042 to access the updated product. 

The Urgent Product Correction information has been published on the TGA website: https://apps.tga.gov.au/PROD/DRAC/arn-detail.aspx?k=RC-2026-RN-00275-1