Description of Event or Problem · 0
I AM A PERSON LIVING WITH INSULIN-DEPENDENT DIABETES AND A CURRENT USER OF THE DEXCOM G6 CONTINUOUS GLUCOSE MONITOR (CGM). I AM SUBMITTING THIS COMPLAINT TO THE FDA TO REQUEST URGENT INVESTIGATION AND INTERVENTION REGARDING TWO PRESSING ISSUES: THE PLANNED DISCONTINUATION OF THE DEXCOM G6 DEVICE IN 2026, AND SERIOUS ACCURACY AND SAFETY CONCERNS SURROUNDING THE DEXCOM G7 CGM, INCLUDING MULTIPLE REPORTS OF ADVERSE HEALTH OUTCOMES AND EVEN DEATHS. 1. SAFETY CONCERNS WITH THE DEXCOM G7 CGM THERE IS A GROWING VOLUME OF EVIDENCE--INCLUDING A NATIONAL CLASS ACTION LAWSUIT (GRISOLI V. DEXCOM, INC., CASE NO. 8:25-CV-02333)--INDICATING THAT THE G7 DEVICE FAILS TO DELIVER CONSISTENT AND ACCURATE READINGS. USERS HAVE REPORTED UNACKNOWLEDGED LOWS, MISSED ALARMS, SENSOR FAILURES, AND SERIOUS EPISODES OF HYPOGLYCEMIA, RESULTING IN EMERGENCY ROOM VISITS, HOSPITALIZATIONS, SEIZURES, AND IN SOME CASES, DEATH. THESE CLAIMS ARE SUPPORTED BY A SERIES OF INDEPENDENT INVESTIGATIONS AND PATIENT INTERVIEWS, INCLUDING THOSE CONDUCTED BY THE MEDIA OUTLET HUNTERBROOK, WHICH DETAILED SERIOUS RISKS ASSOCIATED WITH G7 INACCURACIES. 2. ELIMINATION OF A SAFER, PROVEN TECHNOLOGY: G6 DEXCOM HAS PUBLICLY ANNOUNCED THAT G6 MANUFACTURING WILL CEASE IN 2026. THIS IS DEEPLY ALARMING GIVEN THE UNRESOLVED SAFETY CONCERNS ASSOCIATED WITH ITS REPLACEMENT, THE G7. THE G6 HAS BEEN SHOWN TO BE RELIABLE, ACCURATE, AND EFFECTIVE--PARTICULARLY FOR PEOPLE LIKE ME WHO USE IT WITH INSULIN DELIVERY SYSTEMS (E.G., TANDEM, LOOP). MANY USERS HAVE SIGNIFICANTLY IMPROVED THEIR A1C LEVELS AND REDUCED SEVERE HYPOGLYCEMIC EPISODES WITH THE G6. FORCING PATIENTS TO TRANSITION TO A SYSTEM THAT HAS UNRESOLVED SAFETY ISSUES PUTS OUR HEALTH AT UNACCEPTABLE RISK. 3. LACK OF TRANSPARENCY AND POTENTIAL UNDERREPORTING IT APPEARS THAT NOT ALL G7-RELATED ADVERSE EVENTS ARE BEING CAPTURED IN THE MAUDE DATABASE, DESPITE NUMEROUS FIRSTHAND REPORTS FROM USERS DESCRIBING LIFE-THREATENING FAILURES. THIS RAISES SERIOUS QUESTIONS ABOUT DEXCOM'S ADHERENCE TO MANDATORY REPORTING REQUIREMENTS AND TRANSPARENCY OBLIGATIONS UNDER FDA POST-MARKET SURVEILLANCE GUIDELINES. REQUEST FOR FDA ACTION I URGE THE FDA TO: IMMEDIATELY INVESTIGATE THE SAFETY AND ACCURACY ISSUES REPORTED WITH THE DEXCOM G7 CGM. PLACE A TEMPORARY HOLD OR ISSUE A WARNING ON DEXCOM'S PLANS TO DISCONTINUE THE G6 UNTIL THESE ISSUES ARE FULLY INVESTIGATED AND RESOLVED. REQUIRE THAT DEXCOM TRANSPARENTLY REPORT THE FULL SCOPE OF ADVERSE EVENTS RELATED TO THE G7. ENSURE THAT PATIENTS CONTINUE TO HAVE ACCESS TO SAFE, EFFECTIVE, AND RELIABLE MEDICAL DEVICES--ESPECIALLY IN CASES WHERE THE ALTERNATIVE IS DEMONSTRABLY RISKIER. THIS SITUATION BEARS TROUBLING SIMILARITIES TO PAST INCIDENTS IN THE DIABETES DEVICE AND INSULIN MARKETS, WHERE OLDER, TRUSTED PRODUCTS WERE REMOVED, LEAVING PATIENTS WITH NO SAFE ALTERNATIVES. PATIENT CHOICE, SAFETY, AND PUBLIC HEALTH MUST COME BEFORE CORPORATE TRANSITIONS. PLEASE DO NOT ALLOW THE G6 TO BE DISCONTINUED WHILE THE SAFETY PROFILE OF THE G7 REMAINS IN QUESTION. PEOPLE WITH DIABETES DESERVE ACCESS TO TOOLS THAT HELP US STAY ALIVE--NOT TOOLS THAT ENDANGER OUR LIVES. SINCERELY.