Tandem t:slim X2 Insulin Pump Priority 2 - Warning

16/12/2025
Medical devices HPRA safety notice

Point of information Details
Device Manufacturer/Supplier Information 

Tandem Diabetes Care/Air Liquide Healthcare Ireland

Target Audience Patients / Users of these devices / Healthcare professionals and healthcare settings involved in the use and/or provision of these devices.
What devices are affected?

t:slim X2 insulin pump

Problem or issue? 

Tandem has identified that certain t:slim X2 insulin pumps include a speaker version that has a higher rate of malfunction which may appear as a 'Malfunction 16’ event on your pump. This is due to a wiring issue within the speaker. If a ‘Malfunction 16’ is declared on your pump, insulin delivery will stop, and the pump is no longer operational.

What is the risk?

If this issue occurs it could result in hyperglycemia due to the malfunction, resulting in the stoppage of insulin delivery as well as the real time continuous glucose monitoring, estimated glucose values, and blood glucose trend information. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. 

Why is the HPRA issuing the safety notice?

The HPRA is issuing this safety notice to ensure adequate awareness of this issue and to ensure that users undertake the actions outlined in the manufacturers FSNs. The manufacturer will be releasing a software update in the coming months aimed at enhancing early detection of speaker failure.

What advice has the HPRA for users of these devices? 

  1. Refer to the accompanying FSN’s and follow the instructions provided by the manufacturer. Please note, there are two FSN’s related to this issue; an FSN specific to pumps that have been in use less than 2 years or for users who are less than 18 years of age and an FSN for all other t: slim X2 insulin pump users. 
  2. If you receive a ‘Malfunction 16’ alert on your insulin pump: a. Promptly acknowledge it by pressing “Silence Alarm”. b. Contact Air Liquide to report the malfunction and to initiate the return and replacement of your pump. c. Switch to your backup method of insulin delivery as directed by your health care professional. 
  3. If you haven’t had a ‘Malfunction 16’ occur, you may continue using your Tandem pump as described in the User Guide, but with added precautions as the ‘Malfunction 16’ can occur at any time.
  4. Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 
  5. Be prepared with a backup method of insulin delivery as directed by your physician.
  6. If you are using a Dexcom sensor, use the Dexcom mobile app as a secondary means of CGM alerts and alarms. 
  7. Report any safety issues associated with these devices to the manufacturer and to the HPRA.

Contact Information

 ManufacturerAuthorised Representative Distributor 
Name:Tandem Diabetes Care, Inc.MDSS GmbHAir Liquide Healthcare Ireland Ltd
Address:12400 High Bluff Drive, San Diego, CA,92130Schiffgraben 41, Hannover, Germany ,3017525/28 N Wall Quay, North Wall, Dublin, D01 H104, Ireland
Email:MTrier@tandemdiabetes.comvigilance@mdssar.comhealthie@airliquide.ie
Telephone:+1 805 297 9106+49 511 6262 86301800 12 4912
Website: www.tandemdiabetes.comwww.mdss.comwww.makingdiabeteseasier.com/uk

HPRA Contact Information

All safety issues relating to medical devices should be reported to the HPRA using any of the following reporting options:

Further information on the role of the HPRA in relation to medical devices is available on the regulation of medical devices section of the HPRA website.

Any enquiries regarding this safety notice or any medical device safety issue should be emailed to us using our online contact form.

 

Documents

Tandem Diabetes_ t slim x2_Priority2_Warning_HPRA Safety Notice PDF : 203KB | 16/12/2025 t slim x2_Tandem Diabetes_FSN1 for users PDF : 173KB | 15/12/2025 t slim x2_Tandem Diabetes_FSN2 for users PDF : 165KB | 15/12/2025

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