Tandem t:slim iOS App Recall Due to CGM Pairing Failure
Tandem Diabetes Care is recalling a beta version of its t:slim iOS app because it fails to pair with Abbott FreeStyle Libre 3 Plus sensors, forcing users into manual mode.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that forces users into manual mode, creating a risk of hypoglycemia or hyperglycemia. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Tandem Diabetes Care, Inc. is recalling a beta (early-release) version of the t:slim mobile application for iOS, specifically software version 2.13 distributed via TestFlight. The recall affects 177 units distributed nationwide in the United States.
The software issue prevents the t:slim application from successfully pairing with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors. As a result, the insulin pump cannot establish a near-field communication (NFC) connection with the CGM. This forces FSL3P users to operate their t:slim insulin pumps in manual mode, preventing them from accessing glucose values within the app or using automated control (closed-loop) mode.
The inability to use automated control mode could lead users to experience hypoglycemia or hyperglycemia. Consumers using this specific beta version of the software should be aware of the pairing failure and the resulting limitation in pump functionality.
The recalled product
- Product
- Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
- Manufacturer
- Tandem Diabetes Care, Inc.
- Affected units
- 177
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
Distribution
Distributed nationwide across the United States.
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