OECDReference EN/AU/PS1100739
t:slim X2 Insulin Pump
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- t:slim X2 Insulin Pump
Official information
Risk and measures
- Risk or hazard
- The insulin pump may experience software issues which may disrupt insulin delivery. 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.
- Recommendations
- 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 diabetes@amsl.com.au.
Official information
Economic operators
- Manufacturer
- Australasian Medical & Scientific Ltd
Territory
Geography
- Origin
- United States
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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