Hi All,
I saw this post on the FUDiabetes website. Anyone know anything about this?
The FDA has posted their warning letter to Dexcom of March 4 on quality control issues with G6 and G7 sensors. It reveals some of the technical issues with verifying the accuracy of the sensors. There are no issues concerning sanitary conditions or other things relevant to users.
This letter had been mentioned in another thread as possibly contributing to the current shortage of G7 sensors in the US market.
I did a Google search and found a number of articles on the topic although most of not all were medical websites and not media such as CNN. One is medtechdive dot com/
news/dexcom-warning-letter-cgm-coating-change/743597/.
The warning letter below is on the FDA’s website but may be more technical than most want to read.
fda dot gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dexcom-inc-700835-03042025
Jess @Jsich the FDA letter sent a month ago is, as I understood then, a formal follow on looking for information regarding the “sensor issues” reported to Dexcom by users.
I believe the review began last autumn and appears to me to have been around the time users were making noise about Dexcom limiting replacements.
As you may remember, Dexcom made it very clear that it would replace all sensors that failed to deliver 10 days service due to sensor malfunction.
@Jsich An FDA warning letter and primary finding of adulterated medical device is a very serious situation for Dexcom. Yes it most certainly can contribute to shortages. I read the majority of the findings and think that this is an issue of justification (better explanation) for glucose, acetaminophen, and oxygen detection and bench standards, as well as a change in procedure for the way Dexcom QA calibrates the sensors. If Dexcom fails to address the more serious issues then there will be more serious outcomes including shutdown of manufacturing. Most companies when faced with this, will correct deficiencies and institute better procedures.
Hey Jess, did you read the letter and see the part about compression lows being attributed to the compression causing low O2 and the low O2 affects the sensor? I don’t know how close to reality the theory is but if you happen to have a finger O2 sensor in the house try using it the next few times your Dexcom wakes you up in the middle of the night.
Thanks to everyone who replied. I did not read the letter yet but can give it a try. I do hope they address the issues! I still do finger sticks a few times a day to check it against the Dexcom, but have come to really rely on it much of the time. Chris I do not have an O2 sensor, but that is an interesting thought!