Description of Event or Problem · 0
FDA MEDWATCH VOLUNTARY REPORT: DEXCOM G7 SENSOR FAILURESDEVICE INFORMATION DEVICE: DEXCOM G7 CONTINUOUS GLUCOSE MONITORING (CGM) SENSOR MANUFACTURER: DEXCOM, INC. DESCRIPTION OF THE PROBLEM: OVER A 90-DAY PERIOD, FOUR DEXCOM G7 SENSORS FROM MY SUPPLY FAILED. THE FAILURES OCCURRED AS FOLLOWS: TWO CONSECUTIVE FAILURES DURING TRAVEL : WHILE TRAVELING FOR WORK, TWO SENSORS FAILED BACK-TO-BACK, LEAVING ME WITHOUT RELIABLE GLUCOSE MONITORING. THE SENSOR DISPLAYED A "FAILED SENSOR" ERROR WITHIN 3 HOURS AND STOPPED FUNCTIONING. ANOTHER TIME A SENSOR FAILED TO START, DISPLAYING A "FAILED SENSOR" ERROR DURING THE 30-MINUTE WARM-UP PERIOD. TWO OTHER SENSORS DETACHED PREMATURELY FROM THEIR ADHESIVE PATCHES DESPITE PROPER INSERTION PROTOCOLS TO THE LETTER. THESE SENSORS BECAME NON-FUNCTIONAL WELL BEFORE THE 10-DAY LIFESPAN. HEALTH AND SAFETY IMPACT: THESE FAILURES POSE A SIGNIFICANT HEALTH RISK, AS THE DEXCOM G7 IS CRITICAL FOR MANAGING MY DIABETES. DURING TRAVEL, THE CONSECUTIVE FAILURES LEFT ME WITHOUT CONTINUOUS GLUCOSE MONITORING, INCREASING THE RISK OF UNDETECTED HYPO- OR HYPERGLYCEMIA. EVEN MY BACKUP SENSOR FAILED, EXACERBATING THE ISSUE. THE FREQUENT SENSOR FAILURES HAVE ALSO CAUSED A FINANCIAL BURDEN, AS REPLACEMENTS ARE NOT ALWAYS PROMPTLY PROVIDED AND IN MANY CASES, I END UP EATING THE COST. CONTACTING DEXCOM TECHNICAL SUPPORT (1-844-832-1810) HAS BEEN CHALLENGING, WITH DELAYS IN PROCESSING REPLACEMENTS, FURTHER COMPLICATING DIABETES MANAGEMENT DURING THESE INCIDENTS. I FOLLOWED DEXCOM'S INSERTION PROTOCOLS METICULOUSLY, INCLUDING SITE PREPARATION AND USING RECOMMENDED PLACEMENT. THE FAILURES OCCURRED UNDER NORMAL CONDITIONS, WITH NO EXPOSURE TO EXCESSIVE MOISTURE, PRESSURE, OR INTERFERING FACTORS (E.G., MEDICATIONS LIKE ACETAMINOPHEN). PLEASE HELP. (B)(6). REFERENCING REPORTS MW5172507, MW5172508, AND MW5172509. PT CODE: 4582. DEVICE CODE: 2917.