FDA-Device2022-06-22Class II
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care Inc
Hazard
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Sold states
International distribution in the country of Australia.
Affected count
5,206
Manufactured in
11075 Roselle St, San Diego, CA, United States
Products
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1258-2022Don't want to check this manually?
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