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TGA raises alarm after software errors detected in insulin pump

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Australians with diabetes are being asked to check their insulin pumps after errors were detected in one model's software.

Errors affecting battery life and insulin delivery have been detected in the t:slim X2 insulin pumps from Australasian Medical and Scientific (AMSL), the Therapeutic Goods Administration (TGA) said in a product defect correction.

Anyone who uses this insulin pump with software versions 6.4.1 or earlier has been urged to get in contact as soon as possible by emailing diabetes@amsl.com.au or calling 1300 851 056 to arrange an update of the pump's software.

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The company said insulin pumps running on software versions above 6.4.1 are not affected.

Those using the pumps can check which version of the software they have by selecting: Options → My Pump → Pump Info on the home screen.

Users should then scroll through the pump Info screen using the up/down arrows and find the software version number.

"You can continue using your t:slim X2 pump as described in the device user guide, but you should have an alternative means of insulin therapy available in case the problem cannot be immediately resolved," the TGA said.

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"If unsure about which alternative insulin therapy is right for you or the amount of insulin to inject, contact your doctor or diabetes care specialist."

The TGA said if insulin delivery is stopped, this could result in hyperglycaemia.

"In severe cases of hyperglycaemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional," the department said.

"The sponsor has received several complaints and adverse event notifications linked to these three problems since 2018."

Visit the TGA website for full details about the product defect correction.



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