Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
- Date
- Aug 7, 2025
- Company
- Tandem Diabetes Care, Inc.
- Brand
- Tandem Diabetes Care, Inc.
- Product
- t:slim X2 insulin pumps
- Reason
- Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery
- Hazard
- Other
- Source
- FDA
How to identify the product
- Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.
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Facts are taken from the official notice. If anything here differs from it, the official notice is correct.