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:
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.