Dexcom’s FDA warning letter reveals unauthorized changes to sensors
“The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors.”
“The FDA raised other concerns in the warning letter, including procedures to monitor the glucose and acetaminophen concentrations used in testing of the G6 and G7 CGMs. The FDA also cited problems with Dexcom’s handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels.”
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PBJ
#2
Concerning and the company seems to be acting sort of sketchy. I have been using the Stelo, and it seems pretty accurate, but probably would not rely on these if I was diabetic.
I just had a lab test and the result was within about 2 points.
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No doubt Dexcom is trying to avoid cannibalising its high margin prescription business with its OTC products. You can imagine the board room discussions.
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