100,000 people in the US alone die of diabetes per year (none of the 7 were in the US). Other reporting shows that 3 million glucose meters are being recalled. Diabetes can be tricky to manage as it is.
One could look at this story case-by-case and what happened to the affected individuals. Did the device directly lead them to harm? Of the wide coverage of this story, I see no testimonials from affected people.
We're left with the statistical perspective. I don't see the math supporting this story. I expect that as many or more people would have been harmed by diabetes during the time period without this bug.
I think it is more harmful to perpetuate the lack of context or analysis that brings crowds to look at statistical noise and agree that something must be done about it.
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.
One could look at this story case-by-case and what happened to the affected individuals. Did the device directly lead them to harm? Of the wide coverage of this story, I see no testimonials from affected people.
We're left with the statistical perspective. I don't see the math supporting this story. I expect that as many or more people would have been harmed by diabetes during the time period without this bug.
I think it is more harmful to perpetuate the lack of context or analysis that brings crowds to look at statistical noise and agree that something must be done about it.