Voluntary Medical Device Correction
Malfunction 16 Speaker Issue - t:slim X2 Insulin Pump
July 2025
Tandem Diabetes Care has issued a voluntary medical device correction for a subset of t:slim X2 pumps regarding a potential speaker-related issue that can trigger a Malfunction 16 error resulting in a discontinuation of insulin delivery.
How to determine if your t:slim X2 pump is impacted
If you're not sure if your device is impacted, you can search for your serial number below. Your t:slim X2 pump serial number can be found on the original packaging, on the body of the pump under the cartridge, or by navigating to the pump information screen.
Serial Number Lookup
This serial number IS ON the list, please refer to the Medical Device Correction letter sent to impacted customers.
The serial number IS NOT ON the list, please continue using the pump according to User Guide instructions.