Description of Event or Problem · 0
(B)(6) DEXCOM ACCOUNT EMAIL: (B)(6) MARCH 16, 2026 U.S. FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 10903 NEW HAMPSHIRE AVENUE SILVER SPRING, MD 20993 CC: DEXCOM, INC. 6340 SEQUENCE DRIVE SAN DIEGO, CA 92121. DEAR SIR OR MADAM, I AM WRITING TO REPORT MY PERSONAL EXPERIENCE USING THE DEXCOM G7 CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM. I AM A CURRENT USER OF THIS DEVICE AND HAVE ENCOUNTERED REPEATED PROBLEMS THAT HAVE AFFECTED MY ABILITY TO RELY ON THE READINGS IT PROVIDES. THE PURPOSE OF THIS LETTER IS TO DOCUMENT MY EXPERIENCE AND REQUEST THAT THE RELIABILITY OF THE DEXCOM G7 SYSTEM BE REVIEWED. DURING MY USE OF THE DEXCOM G7, I HAVE EXPERIENCED A VERY HIGH RATE OF SENSOR PROBLEMS. BASED ON MY EXPERIENCE, A CONSERVATIVE ESTIMATE IS THAT MORE THAN 50 PERCENT OF THE SENSORS I HAVE USED HAVE FAILED IN ONE WAY OR ANOTHER. THESE FAILURES INCLUDE SENSORS STOPPING EARLY, FAILING DURING STARTUP, OR PROVIDING READINGS THAT APPEAR INCONSISTENT WITH FINGER-STICK VERIFICATION. DEXCOM SHOULD BE ABLE TO VERIFY THE FREQUENCY OF THESE FAILURES THROUGH MY ACCOUNT HISTORY ASSOCIATED WITH THE EMAIL ADDRESS LISTED ABOVE. BECAUSE I RELY ON THIS DEVICE TO GUIDE MY GLUCOSE MANAGEMENT DECISIONS, INACCURATE OR UNRELIABLE READINGS HAVE DIRECTLY AFFECTED MY SAFETY. ON MULTIPLE OCCASIONS I HAVE MADE DECISIONS BASED ON CGM READINGS THAT LATER PROVED TO BE INCORRECT WHEN VERIFIED BY FINGER-STICK TESTING. SITUATIONS LIKE THIS CREATE UNCERTAINTY ABOUT WHETHER THE INFORMATION PROVIDED BY THE DEVICE CAN BE TRUSTED AT THE MOMENT IT IS NEEDED. I WOULD ALSO LIKE TO NOTE THAT MY WIFE IS A REGISTERED NURSE WHO WORKS WITH DIABETIC PATIENTS AND APPLIES MOST OF MY SENSORS. I THEREFORE HAVE ACCESS TO INFORMED GUIDANCE ON THE PROPER USE OF CGM SYSTEMS. THE PROBLEMS DESCRIBED ABOVE ARE NOT THE RESULT OF IMPROPER USE OR MISUNDERSTANDING OF THE DEVICE. I UNDERSTAND THAT INDIVIDUAL DEVICES CAN FAIL OCCASIONALLY. HOWEVER, THE FREQUENCY OF PROBLEMS I HAVE EXPERIENCED WITH THE DEXCOM G7 HAS BEEN SIGNIFICANT ENOUGH THAT I BELIEVE IT SHOULD BE FORMALLY DOCUMENTED AND REVIEWED. I AM SUBMITTING THIS LETTER SO THAT MY EXPERIENCE BECOMES PART OF THE OFFICIAL RECORD. I RESPECTFULLY REQUEST THAT THE FDA REVIEW POST-MARKET COMPLAINT DATA RELATED TO THE DEXCOM G7 SYSTEM TO DETERMINE WHETHER RELIABILITY ISSUES SIMILAR TO THOSE I HAVE EXPERIENCED ARE OCCURRING MORE BROADLY. A COPY OF THIS LETTER IS BEING PROVIDED TO DEXCOM SO THE COMPANY IS AWARE OF MY EXPERIENCE AND HAS THE OPPORTUNITY TO REVIEW THE CONCERNS DESCRIBED ABOVE. SINCERELY, (B)(6).