FAQ: AMSL and Tandem Diabetes Care t:slim X2 insulin pump

FAQ for healthcare professionals (AMSL)

Friday, 27 November 2020

AMSL have published a detailed FAQ for healthcare professionals.

These include:

1. What are the TGA’s specific safety concerns?
There are a combination of hardware and software concerns. We are awaiting further guidance from the TGA before sharing additional information publicly.

2. How long will this suspension be for?
The suspension will be for 6 months as of 24th November and will end on 24th May 2021, unless lifted earlier.

3. Does this suspension affect any other countries?
No, this product suspension has been identified by the TGA and therefore only affects Australia.

4. Do we need to recall pumps in the market?
We have not been directed to recall pumps from the market.

5. Can we continue to supply replacement pumps and consumables?
Yes, existing customers will continue to be supported by AMSL Diabetes and will still be able to access consumables. In-warranty customers will continue to be eligible for replacements under their existing warranty policy.

6. Is the t:slim X2 still suitable for use?
The TGA have confirmed that existing customers can remain on their Tandem insulin pumps while AMSL Diabetes and Tandem work towards resolving their concerns.

7. Customer: I don’t feel safe on the t:slim X2, what do I do?
Please contact our Customer Care Team on diabetes@amsl.com.au outlining your details and concerns and our team will review your situation.

The FAQs also address ‘Customer Enquiries – Ongoing Supply & Orders.’

Read AMSL’s FAQ for healthcare professionals .


Frequently asked questions (ADEA)

Thursday, 26 November 2020

This is not a safety notice by the TGA. There would have been a safety notice issued if there were safety issues. We advise CDEs that they can refer to the statement issued by AMSL:

‘Existing t:slim X2 insulin pump users can continue to use their pump and order infusion sets and reservoirs/cartridges as usual.’

Yes. No safety issue has been noted by the TGA, and we understand that AMSL is working with the TGA to correct the issue.

Contact AMSL Diabetes: : diabetes@amsl.com.au or 1300 851 056. They will continue to replace pumps under the existing warranty policy.


Statement to ADEA members, 26 November 2020 (updated 27 November 2020)

As you are possibly aware, AMSL has issued a statement regarding the TGA and their Tandem Diabetes Care t:slim X2 insulin pump.

We’ve been in discussions with AMSL and have been advised that this is not a safety issue, but an alert.

AMSL has stated ‘There are a combination of hardware and software concerns. We are awaiting further guidance from the TGA before sharing additional information publicly.’

People who are using pumps can continue to use them. The consumables are still available through the NDSS.

More info:

AMSL Diabetes issued a statement to consumers and healthcare professionals this week, saying that the Therapeutic Goods Administration (TGA) has ‘expressed concern about the Tandem Diabetes Care t:slim X2 insulin pump’:

‘…the TGA have informed us of their intent to temporarily suspend the ARTG entry for the t:slim X2 insulin pump as of 24th November, 2020.

‘Existing t:slim X2 insulin pump users can continue to use their pump and order infusion sets and reservoirs/cartridges as usual. AMSL Diabetes will continue to replace t:slim X2 insulin pumps under the existing warranty policy.’

We have spoken with AMSL and they wish to reassure CDEs and people with diabetes  that this is not a recall, and that nothing will change for current users of the t:slim X2 insulin pump.

The suspension does prevent new orders being made and will last for 6 months, ending 24th May, 2021, unless lifted earlier.

If you have any questions, the contact details for CDEs and consumers is: diabetes@amsl.com.au or 1300 851 056.

The TGA has not yet issued an official notice but we will keep you informed of any relevant updates.

Frequently asked questions

We will update these  as needed over the coming weeks.

Regards,

ADEA Team


Last updated: Friday, 27 November 2020