Dexcom Hit With Warning Letter
This morning the FDA posted a warning letter that was sent to Dexcom (NASDAQ:DXCM) back on May 21, 2010. Looking over the letter the FDA’s main concern, which stems from a Dexcom planet inspection conducted January 11, 2010 through February 8, 2010, is centered on how the company handles adverse event reports. The letter sites several examples of how the company’s procedures were inadequate and contains the following paragraph;
“Your response dated March 2, 2010 stated that you have agreed to submit sensor wire fractures as MDRs going forward for all complaints of fractured wires received after January 1, 2008. You stated that seventy-three MDR reports were to be filed for all complaints; however, the evidence collected during the establishment inspection documented that you group multiple events within anyone complaint which indicates that there are likely more than 73 individual complaints of fractured sensor wires. Each event should be reported as an individual event under Medical Device Reporting. You also stated that your MDR review and reporting procedures were revised and training completed. However; documentation of the review and procedures was not provided in the response.”
The letter also raises concerns over off-label use of the Seven Plus systems and recommends the following changes be made to the labeling, patient brochure and company web site;
“Under the Warnings section, warn the user: (1) not to remove a retained sensor probe distal segment, unless it is clinically indicated; and (2) to contact the health care provider for medical advice in the event of a sensor probe fracture.
• Revise the Precautions bullet to state: The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis, and move this bullet to the Warnings section.
• Add a Limitations of Use section to reiterate the above warning: The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis, and move it to the Warnings section.
• Under the Warnings section, include the following statement: The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion in sites other than in the skin of the abdomen.”
While a warning letter from the FDA is never a good thing, Diabetic Investor is hardly surprised given the FDA’s concern over medical device usage. We further believe the Street, as usual, is overacting to this news. Terry Gregg, the company’s President and CEO, who has done an excellent job of turning the company around since he took command will take every step necessary to insure that Dexcom remains on track to become the leader in CGM technology. Diabetic Investor is confident this is just a blip in the road and not a major derailment.
Surly we’ll hear more about what steps the company plans on taking when they conduct a conference call at 1:15 pm PST.
