URGENT MEDICAL DEVICE CORRECTION
Malfunction 16 – Speaker
t:slim X2 Insulin Pump

July 22, 2025

The purpose of this letter is to advise you that Tandem Diabetes Care is voluntarily initiating an Urgent Medical Device Correction for t:slim X2 insulin pumps that may exhibit a higher rate of speaker failure. You are receiving this letter because our records indicate you may be operating an affected t:slim X2 insulin pump.

If you receive this Urgent Medical Device Correction notice, it is important to acknowledge receipt of this notice by completing the online form available at the following link or by using the QR code below: Campaign.tandemdiabetes.com/FCA-Malfunction-16

To confirm whether your pump is affected, please click the following link: URGENT Malfunction 16 / t:slim X2

What is the potential issue?  During normal use, the t:slim X2 insulin pump software monitors current flowing through the speaker during use. Measurements falling within a pre-determined range indicate a functioning speaker while measurements falling outside the range indicate a speaker failure.  When current measurements fall outside of the expected range, a malfunction is declared (“Malfunction 16”).

Tandem has identified certain speaker versions that have a higher rate of Malfunction 16 events 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. If this happens, please contact Tandem Diabetes Care Customer Technical Support (CTS) via phone at 1-877-801-6901 or email at
Techsupport@tandemdiabetes.com.

Risk:  A Malfunction 16 will stop insulin delivery and terminate communication between the insulin pump and the CGM device, as well as the Tandem t:slim mobile app. If not addressed, this could result in hyperglycemia due to the malfunction resulting in the stoppage of insulin delivery and real time CGM Estimated Glucose Values (EGVs) and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. 

There have been 700 adverse events reported and 59 reported injuries. There have been no reports of death.

Read more: URGENT MEDICAL DEVICE CORRECTION: Tandem t:slilm Malfunction 16 – Speaker