Tandem t:slim X2 and Mobi insulin pumps recalled for unexpected insulin bolus with Dexcom G7
What this means
Tandem Diabetes Care insulin pumps (t:slim X2 and Mobi models) with certain software versions may deliver an unexpected automatic insulin correction dose when paired with a Dexcom G7 sensor. This could cause low blood sugar (hypoglycemia). The issue affects specific software versions: t:slim X2 versions 7.9.0.1 and 7.10.1, and Mobi version 7.9.0.1.
- If you use a t:slim X2 or Mobi pump with Control-IQ+ and a Dexcom G7 sensor, check your pump's software version in the settings menu.
- Update your pump software to the latest version available through the Tandem t:connect app or contact Tandem support.
- Review the updated User Guide that came with your update (revision D for t:slim X2, revision C for Mobi).
- Monitor your blood sugar closely and watch for signs of low blood sugar until your pump is updated.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2026Want us to check the next one for you?
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