Accu-Chek Solo Cannula Assembly & Pump Holder (9 mm; 10+3 & 6 mm; 10+3) and Accu-Chek Solo Supply Kit (9 mm) & (6 mm)
Cannula lot numbers: 847468303 and lower
Reference numbers: 07858833001, 07858841001, 07858817001 & 07858825001
(Roche Diabetes Care Australia Pty Ltd - Insulin infusion patch pump administration set)
(Roche Diabetes Care Australia Pty Ltd - Ambulatory insulin infusion administration set/reservoir kit)
What are the defects?
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder.
If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.
What are the hazards?
If insulin is under-delivered, this may lead to adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a medical professional.
What should consumers do?
Consumers should check whether they have an affected product and if so stop using them. Consumers should contact Roche Diabetes Customer Care to make arrangements to receive a replacement.
For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01541-1
For further information, please contact Roche Diabetes Customer Care by phone on 1800 251 516.