FDA-Device2025-10-01Class II
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Tandem Diabetes Care, Inc.
Hazard
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
Sold states
International distribution to the country of Israel.
Affected count
19
Manufactured in
12400 High Bluff Dr, N/A, San Diego, CA, United States
Products
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2025Don't want to check this manually?
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