Tandem t:slim mobile app iOS 2.13 recalled for FreeStyle Libre 3 Plus pairing failure
What this means
A beta version of the Tandem t:slim iOS app (version 2.13) has a software bug that prevents it from connecting to Abbott FreeStyle Libre 3 Plus glucose monitors. Users affected by this issue cannot see their blood sugar readings in the app and cannot use automated insulin delivery; they must switch to manual pump mode instead.
- If you use a t:slim pump with FreeStyle Libre 3 Plus, do not use the iOS app version 2.13 (TestFlight beta).
- Contact Tandem Diabetes Care for instructions on returning to a working app version.
- Switch your pump to manual mode until you receive a corrected app version.
The agency's original wording
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3330-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.