The deaths are associated but not necessarily caused by the incorrect readings, but as is often the case, medical interventions treat all observed conditions as side effects (this is similar in the case of drug and device trials), and the FDA has typically operated from an abundance of caution (though policies are somewhat erratic under the current administration).
I share the skepticism of the top-level comment by jimrandomh, in I understand that CGMs are used to guide treatment but not determine it, and that the consequence of spurious low blood-glucose readings is not likely to be immediately threatening (that is: the consequence of mistreating based on the mis-reading would be an actual high blood glucose event), though of course over the long term, high blood glucose levels are precisely the mechanism by which long-term and late-stage diabetes symptoms and conditions emerge.
Given the large number of devices (38% of US adults, or ~125 million), and millions of CGMs in use, seven associated deaths seems a relatively low number and correspondingly low risk.
TFA also would seem to misclassify the problem as one principally of software where the actual principle issue would be of potential patient noncompliance with protocols. That itself is complex, and isn't necessarily a matter of blame (the very young, otherwise ill, or cognitively-impaired might well be expected to comply poorly with instructions), but is a concern providers and dispensing pharmacists would have to be exceedingly cognizant of. As well as device manufacturers.
As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.
<https://www.fda.gov/medical-devices/medical-device-recalls-a...>
The deaths are associated but not necessarily caused by the incorrect readings, but as is often the case, medical interventions treat all observed conditions as side effects (this is similar in the case of drug and device trials), and the FDA has typically operated from an abundance of caution (though policies are somewhat erratic under the current administration).
I share the skepticism of the top-level comment by jimrandomh, in I understand that CGMs are used to guide treatment but not determine it, and that the consequence of spurious low blood-glucose readings is not likely to be immediately threatening (that is: the consequence of mistreating based on the mis-reading would be an actual high blood glucose event), though of course over the long term, high blood glucose levels are precisely the mechanism by which long-term and late-stage diabetes symptoms and conditions emerge.
Given the large number of devices (38% of US adults, or ~125 million), and millions of CGMs in use, seven associated deaths seems a relatively low number and correspondingly low risk.
TFA also would seem to misclassify the problem as one principally of software where the actual principle issue would be of potential patient noncompliance with protocols. That itself is complex, and isn't necessarily a matter of blame (the very young, otherwise ill, or cognitively-impaired might well be expected to comply poorly with instructions), but is a concern providers and dispensing pharmacists would have to be exceedingly cognizant of. As well as device manufacturers.