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QUOTED. 22 May 2019. US FDA.

Executive Summary

The US FDA is warning diabetic patients that using unauthorized devices and unauthorized algorithms could have serious consequences. This comes after a patient who used such devices nearly died. See what the agency said about the serious adverse event here:

“Based on the available information, it is unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor, or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system." –US FDA

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