Memorandum

FDA Sends Dexcom Warning Letter for Administrative Deficiencies in its MDR Reporting – March 25, 2014

Executive Highlights

  • This morning, Dexcom announced that it has received a warning letter from the FDA related to administrative deficiencies in filing medical device reports (MDRs).
  • Dexcom expects to resolve the deficiencies and close out the warning letter by the end of April 2014.
  • Management emphasized that the letter will not slow down the pending FDA reviews of the Animas Vibe, Dexcom Share, or G4 Platinum professional use indication. No FDA sanctions were levied and Dexcom’s sales and manufacturing are not affected.

This morning, Dexcom announced that it has received a warning letter from the FDA related to administrative deficiencies in filing medical device reports (MDRs). The news stems from a November 2013 inspection of Dexcom’s San Diego, CA headquarters – as we understand it, Dexcom only received the warning letter recently, just another reflection of the scope of the FDA’s job and the associated backlog. MDR reporting requirements were modified in a July 2013 FDA guidance, such that any adverse event requiring third party assistance now requires an MDR (e.g., an MDR is needed for a hypoglycemic episode that required assistance from a third person such as a parent or partner, even if Dexcom’s CGM was working perfectly well and presumably had nothing to do with the hypo!). The November inspection revealed that Dexcom’s reporting to the FDA was not compliant with the updated July 2013 FDA guidance.

The company expects to resolve the deficiencies and resolve the warning letter by the end of April 2014. As we understand it, the biggest change will involve Dexcom’s customer service and support decision trees – certain calls will immediately drop into the MDR tree, and Dexcom will consequently file many more reports with the FDA. (Of course, this is all relative, as management has emphasized over the past year that complaint rates and attrition with the G4 Platinum are much lower than for the Seven Plus – this certainly jives with what we hear from the field and what our sister company dQ&A reports; contact richard.wood@d-qa.com for more information.) The burden is still on patients to contact Dexcom with any problems, at which point the company will determine whether an MDR is required. We are guessing the reality is that most patients won’t blame Dexcom or even contact them, since the intuitive way to treat a low isn’t to call a company but to ingest glucose.

The words “Warning Letter” are often cause for alarm, but in this case, the news does not seem materially concerning for Dexcom’s business. Most importantly, management says the letter will not slow down the pending FDA reviews of the Animas Vibe (filed in 1Q13; 2014 launch expected per comments at JPM 2014), Dexcom Share (filed in July 2013; 2014 launch expected per comments at JPM 2014), or G4 Platinum professional use indication (filed in 3Q13). Additionally, the warning letter does not involve FDA sanctions, will not require patient outreach, and will not impact Dexcom’s sales or manufacturing. Overall, the news is a public relations and administrative hassle for Dexcom, but does not seem like a major patient safety concern (unlike the 2010 FDA Warning Letter). Still it is a clear reminder of the admission price to selling medical devices in the US – the barriers to entry continue to rise and commercialization is about so much more than a well-designed device that meets the FDA’s safe/effective bar. We do note that there are no sanctions because we can’t imagine what FDA would ask Dexcom to do; there isn’t a clear role for the company in our view since they aren’t really associated with any clear problems.

  • This news reminds us of February’s EASD Diabetes Technology conference – a session on the Draft EASD/ADA Statement on the Evaluation of Insulin Pumps included Dr. Anne Peters’ views on the FDA’s adverse event reporting system for medical devices. Following a deep dive into the MAUDE database (26,000 reports on insulin pumps in 2013 – 500 per week!), she concluded that the current data is pretty much useless in terms of understanding anything about insulin pump safety. In addition, her reading of many of the reports revealed that most adverse events actually relate to the user, not a device malfunction. Dr. Peters’ overall takeaway was refreshingly straightforward, “I cannot use this data to understand much about pump safety.”

 

Close Concerns Questions

Q: What will it take to improve the quality of the FDA’s adverse event reporting system?

Q: Does the current adverse event reporting system protect patient safety, or does it create more noise than benefit?

Q: As new medical device companies seek to bring products to market, what is the most challenge piece of commercialization – customer service/support, reimbursement, FDA requirements, sales to physicians, sales to patients, something else?

 

--by Adam Brown and Kelly Close