t:slim X2 Insulin Pump
The t:slim X2 Insulin Pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin.
Product code: 1006419
Software version of 6.4.1 or prior
(Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)
What are the defects?
The insulin pump may experience software issues which may disrupt insulin delivery.
What are the hazards?
The issues may result in under delivery of insulin that may cause hyperglycemia, which can lead to serious health complications.
In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
What should consumers do?
Consumers can continue using the pump as described in the User Guide. It is advised to have an alternate means of insulin therapy available. Please update your pump to the latest software version at the earliest possible opportunity.
For more details, see https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00627-1
For further information, contact Australasian Medical & Scientific Ltd by calling 1300 851 056 or via email at firstname.lastname@example.org.