T:slim X2 Insulin Pump

Official notice

6 Jun 2022

Last checked

6 Jun 2022

High riskACCC

An official ACCC notice concerns T:slim X2 Insulin Pump. 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. Published 2022-06-06.

What to do now

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.

Recall number

db9db5f4-c683-4d44-a18b-e58d33d7f66c

Official notice

2022-06-06

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

304681

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Affected products

Product 1

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 ARTG 304681 (Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

db9db5f4-c683-4d44-a18b-e58d33d7f66c

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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