Tandem Diabetes Care, Inc.: Alternate Controller Enabled Insulin Infusion Pump
Updated under an hour ago ()
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.
- Tags
- FDA recall, medical device, class 2, Clinical Chemistry, Software Design Change, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 7: Security Operations; CISSP 8: Software Development Security; CISM 3: Information Security Program; CISA 3: Information Systems Acquisition, Development and Implementation; CISA 5: Protection of Information Assets
- Source record id
- Z-3330-2026
- First seen by InfoSec Signals
- 10/9/2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.