t:connect iOS app for insulin pump could kill users, says FDA

Version 2.7 of the t:connect iOS app – which is used to control delivery of insulin by the t:slim X2 pump – has been urgently recalled by the FDA.The FDA issued a Class I recall, which is reserved for products likely to cause “serious adverse health consequences or death” ... more...

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Version 2.7 of the t:connect iOS app – which is used to control delivery of insulin by the t:slim X2 pump – has been urgently recalled by the FDA. The FDA issued a Class I recall, which is reserved for products likely to cause “serious adverse consequences or death” .

.. What is an insulin pump? Type 1 diabetes was previously known as insulin-dependent diabetes, as those diagnosed with the condition need regular injections of insulin.



This is because their pancreas makes little to no insulin, meaning sugar is unable to be passed from the blood to cells. This causes sugar to build up in the blood-stream, which can be life-threatening. Manual injections can be inconvenient, and are subject to human error (like forgetting one), so insulin pumps are a better solution for many.

These automatically inject specific amounts of insulin when required, based on blood sugar measurements. Automatic pumps also operate while users are sleeping. Pumps like the the t:slim X2 are controlled by an iOS app, which tells them when to inject insulin, and how much to inject.

t:connect iOS app recall Version 2.7 of the t:connect iOS app has been found to crash, and is now . is the most urgent of the three categories, and is used only when “there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

” A bug in the app is causing it to repeatedly crash and restart. Each time it does, it establishes a new Bluet.