Tandem Diabetes Care, Inc.: t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when u
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Tandem Diabetes Care, Inc.
- Product
- t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
- Reason / hazard
- A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US nationwide distribution including Puerto Rico.
- Recall initiated
- 2025-08-05
- Code info
- t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1, User Guide versions not including and prior to: AW-1014562 Revision D; Tandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319 with software version 7.9.0.1, User Guide versions not including and prior to: AW-1014938 Revision C
- Product quantity
- 122,958
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Diego
- State
- CA
- Country
- United States
- Event id
- 97403
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