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The FDA says the recall is for the t:connect mobile app, version 2.7, which operates on Apple iOS and it's used with the t:slim X2 insulin pump that features Control-IQ technology.
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 ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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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Repaglinide lowers blood glucose by stimulating the release of insulin from the beta islet cells of the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells' calcium channels, and the resulting calcium influx induces insulin secretion. [1]
Mylan’s second recall of Insulin Glargine this year. ... let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Then, notify the ...
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