Dexcom Receives Warning Letter from FDA


Dexcom received a warning letter from the FDA.  The letter talked about Dexcom’s failure to submit MDR reports for sensor fractures and grouping those reports together to make it look like there were less cases than there actually were.  The FDA also wants Dexcom to change its labeling regarding use in children, adolescents & pregnant women.  They also want the labeling changed regarding using sensors in places other than the abdomen.

Here is the link to the letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm213414.htm

Dexcom responded quickly and held a conference call this afternoon to let people know what was going on.  They also have the webcast archived on their website under investor relations   First, I have to say that I am impressed with the speedy response by Dexcom.  The Navigator has been on backorder since January and Abbott still has their customers in the dark.

I called the number for the conference call so I could listen in.  Terrence H. Gregg, President and CEO, gave a brief statement then took questions.  Mr. Gregg said that they first began talking to the FDA in 2006 about the problem.  He said that between 2008 and 2010, less than 0.03% of sensors were affected.  He does not feel that the FDA statement about Dexcom grouping the MDR reports together was accurate.  He said that had been corrected when the FDA was there and there were only a total of 73 cases.  That will be addressed in their response to the FDA.  He also said that even though they feel the labeling is clear, they will change it to what the FDA wants.

Mr. Gregg said that they did consult with doctors and various other people to assess the problem of the fractured sensors.

During the question part of the call, someone asked why it took them so long to respond.  He said that they received the letter late last week and today was the first day that they could respond.  I chuckled at that question because they obviously never dealt with Abbott.  Another laugh was a person asking how their competitors reported stuff to the FDA.  I would love to have said that they don’t!  There are now a ton of adverse event reports on the FDA’s website for the Navigator and most of those were submitted by Abbott in April – after customers began filing their own reports.

Someone brought up the Gen4 sensors that are currently being tested.  He said that the sensor wire will be stronger.  He also said that there will be greater accuracy for detecting hypoglycemia.  I think the current system is very accurate but I would never turn my nose down at more accuracy.

Another person asked if there would be any backorders because of the labeling change and he assured everyone that there would not be.  He said that they have to submit the change to the FDA for approval before they can make the changes even though it was recommended by the FDA.

A question was asked if there was any correlation between the length of time that the sensor was worn and the fractures and Mr. Gregg said that there was not.  A lot of people do wear the sensors for 14 and 21 days, not the recommended 7.  I have to wonder if the fractures occurred with someone wearing the sensor for longer than 7 days and if the person would be honest about that when reporting it.

Mr. Gregg was asked how the competition will respond.  He of course had no way of knowing that.  I would love to have asked that person how Abbott could possibly come out and say anything when they have had Navigator parts on backorder for over 4 months now and their customers are still in the dark about what is going on.

I actually planned on writing something today about how much I love my Dexcom – I will save that for next week.  It was very refreshing to hear Dexcom step up to the plate and discuss what is going on.  Thank you Dexcom for actually caring about your customers and keeping us informed of what is going on.
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4 thoughts on “Dexcom Receives Warning Letter from FDA

  1. Hi Kelly,
    Thanks so much for providing the website for the FDA letter. Was able to read about the problems. When I called Dexcom about other possible sensor mounting locations and sensor wire breakage, I was told that sensor wire breakage occurrances are only 3 in 10,000. I was also told that if the sensor wire breaks off in the skin, it should be treated like a splinter… I was also told that the abdomen is the recommended location for the sensor, but since I have scarring in my abdomen after 56 years of insulin injections that I could try another location in fatty tissue not in close proximity to muscle.
    Got my Dexcom 7+ about two weeks ago, but haven’t hooked it up yet. Haven’t figured out where to mount the sensor because I sleep on both my side(L&R)and my stomach. Am considering mounting it on my arm, even though that’s not what they recommend. Have you or anyone else who’s using the Dexcom ever tried any other locations than the abdomen for the sensor?

    • Hi Bertie,

      I haven’t tried it but a lot of people do use their arms. When I had the Navigator, I used my arms for that and would prefer to use my arms for the Dex also. When you go to put the sensor on, you have to squeeze the tabs and also pull the inserter out so you really need two hands to do that – I don’t have anyone to help me so I am stuck using my stomach. I tend to sleep on my sides so I haven’t tried putting the sensor there.

      I was going to put this in my next write-up, but I will go ahead & tell you now since you are a new Dexcom user. TuDiabetes has a Dexcom user group that I joined and there is a wealth of information there. You are able to read posts without joining. You have to join if you want to ask a question or be notified when someone else asks questions. You can get some really good tips there. Here is the link if you are interested:

      http://www.tudiabetes.org/group/dexcomusers

  2. Hi Kelly, You just saved me some time because now I don’t have to go and listen, and I also think that Dexcom deserves credit for dealing with this in public. We have only used abs for sights but this time used lower abs and are thrilled with how close the readings are matching up. It was good before, and great now. I think that there is something to what some people say about the abs moving a bit too much. This sensor has been our best yet. The last one was in almost 3 weeks and the site looks awesome. I won’t be happy if a piece of a sensor stays under her skin, but the risk seems small to me and it was a known risk. I don’t know if it was in the manual or not, because I haven’t read it really. This is so simple to use in comparison that I didn’t feel the need!

    • I was really happy about the way Dexcom handled this. I will have to try lower abs. The guys on TuDiabetes also like love handles. During the question & answer part, someone asked about pregnant women & Dexcom is trying to do some testing on pregnant women. Someone asked where they would stick the sensor. The president said in the love handles. I sleep on my side though so not sure how that would work for me. I wouldn’t be happy either if a piece of sensor broke off and stayed in, but we take a risk with everything we use. I read about that happening on CWD but figured the chances were slim. The only part of the manual I have used is putting the sensor in just to make sure I don’t mess that up. I did look up the recharging time when I did the trial It is so easy to use.

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