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The FDA also encourages users to carry backup supplies for insulin delivery should pump failure persist. Customers with any questions or concerns regarding the recall can reach Tandem Diabetes ...
In November 2011, the company received FDA clearance to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. [10] In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump ...
More than 200 people with diabetes have been injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.
The Tandem Diabetes Care t:Slim X2 was approved by the U.S. Food and Drug Administration in 2019 and is the first insulin pump to be designated as an alternate controller enabled (ACE) insulin pump. ACE insulin pumps allow users to integrate continuous glucose monitors, automated insulin dosing (AID) systems, and other diabetes management ...
Tandem Diabetes (TNDM) receives clearance for expanded indication for pediatric use of t:slim X2 insulin pump with Control-IQ, paving the way for simpler diabetes management in younger patient pool.
Insulin pumps, cartridges, and infusion sets may be far more expensive than syringes used for insulin injection with several insulin pumps costing more than $6,000; necessary supplies can cost over $300. [3] Another disadvantage of insulin pump use is a higher risk of developing diabetic ketoacidosis if the pump malfunctions. [3]
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