Description of Event or Problem · 1
SEVERE RASH AND BLISTERS; MY NAME IS (B)(6) AND I'M A (B)(6) YEAR-OLD WHITE FEMALE AMERICAN. I'VE BEEN USING THE DEXCOM G6 CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, ALSO CALLED BLOOD GLUCOSE SENSORS, SINCE (B)(6) OF 2018 WITHOUT ISSUE UNTIL (B)(6) OF THIS YEAR (2020). I AM A TYPE 1 DIABETIC AND THIS PARTICULAR BRAND OF GLUCOSE SENSOR HAS BEEN LIFE SAVING FOR ME AS I NO LONGER FEEL WHEN MY BLOOD GLUCOSE DROPS TO DANGEROUS LEVELS WITHOUT THE HELP OF MY DEXCOM G6 AND IT IS MEDICALLY NECESSARY. I'VE TRIED ANOTHER BRAND OF GLUCOSE SENSORS WHICH DO NOT WORK FOR ME. I PURCHASED THE DEXCOM G6 BLOOD GLUCOSE SENSORS FROM DEXCOM INC., (B)(4). THERE ARE THREE GLUCOSE SENSORS IN A BOX WHICH LAST TEN DAYS EACH OR 30 DAYS PER BOX. THE LAST TWO MONTHS OF USING MY NEWEST SHIPMENT OF SIX SENSORS, I REALIZED THAT THE ADHESIVE PATCH TO HOLD THE GLUCOSE SENSOR ON THE SKIN HAD BEEN CHANGED. IT IS NOW EXTREMELY DIFFICULT TO REMOVE THE ADHESIVE PATCH (ALMOST LIKE SUPER GLUE) AND IT LEAVES A SEVERE BLISTERED RASH THAT NOW TAKES THREE TO FOUR WEEKS TO DISAPPEAR. EVEN AFTER THE RED RASH AND BLISTERS FADE, THERE IS A HARDENED RING ON MY SKIN WHICH MATCHES THE CIRCUMFERENCE OF THE ADHESIVE PATCH WHICH, HAVE YET, TO GO AWAY. WHENEVER I'VE CALLED DEXCOM TECHNICAL SUPPORT TO ASK IF THE ADHESIVE HAS BEEN CHANGED, I AM TOLD THAT THEY DON'T KNOW. I HAVE HAD LITTLE POSITIVE EXPERIENCE WITH SPEAKING TO DEXCOM REPRESENTATIVES AND THEY WILL NOT CONNECT ME WITH A SUPERVISOR SO I HAVE WRITTEN LETTERS TO THE DEXCOM CEO AND KEY EXECUTIVE TEAM, BUT AS YET, HAVE NOT GOTTEN A RESPONSE. MY SKIN IS DAMAGED FROM THE RASH, BLISTERS AND HARDENED RINGS ON MY SKIN AND I CAN'T APPLY ANOTHER DEXCOM G6 BLOOD GLUCOSE SENSOR ON TOP OF THE DAMAGED SKIN. PLEASE HELP ME AND OTHER CUSTOMERS WHO RELY ON THESE GLUCOSE SENSORS TO KEEP THEM ALIVE AND SAFE AND MAKE DEXCOM CHANGE BACK TO THE ADHESIVE THEY USED TO USE ON THEIR SENSORS. OUR LIVES DEPEND ON IT. FDA SAFETY REPORT ID# (B)(4).