If your email program has trouble displaying this email, view as a webpage.

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery

The FDA is aware that Tandem Diabetes Care sent all affected customers an Urgent Medical Device Correction letter for its certain t:slim X2 Insulin Pumps after identifying a potential speaker-related issue. This issue can trigger an error which will stop insulin delivery and render the pump no longer operational. The use of the affected product may result in insulin delivery stopping and missing real-time reporting of continuous glucose monitoring estimated glucose values and glucose trends, which could cause high blood sugar (hyperglycemia). In severe cases of hyperglycemia, serious adverse health consequences could occur, including the risk of intervention from a medical professional, hospitalization, or even death.

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

This recall involves correcting certain devices through a software update and does not involve removing them from where they are used unless or until a malfunction occurs. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Questions?

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901 or Techsupport@tandemdiabetes.com.