Description of Event or Problem · 0
THE DEXCOM G7 CGM SENSOR IS STATED BY DEXCOM TO BE WORN FOR 10 DAYS. FROM OUR PERSONAL EXPERIENCE AND THAT OF MANY OTHER PATIENTS, IT BECOMES SERIOUSLY UNSTABLE AND INACCURATE PREMATURELY, TYPICALLY AT THE 8TH-9TH DAY. THEY HAVE RECOGNIZED THIS PROBLEM AND WILL PROVIDE PATIENTS A FREE "WARRANTY" REPLACEMENT WHEN REPORTED TO THEM. HOWEVER, THEY ARE NOT ACKNOWLEDGING THE LIFE-THREATENING RISK TO PATIENTS WHEN THIS HAPPENS, ESPECIALLY THOSE WHO ARE USING THE G7 IN A LOOP SYSTEM TO A PUMP. THIS IS OUR CASE. MY HUSBAND'S G7 WENT UNSTABLE, SENDING "BRIEF ERROR" MESSAGES MULTIPLE TIMES SOME TIME YESTERDAY IN ITS 9TH DAY. THESE ERRORS INSTRUCT YOU TO SIMPLY ALLOW TIME FOR IT TO RESTORE. THIS EARLY FAILURE HAS BEEN CONSISTENTLY HAPPENING WITH MULTIPLE G7'S FOR APPROXIMATELY THE PAST 6-8 MONTHS SINCE DEXCOM REVISED THIS SENSOR. OVERNIGHT LAST NIGHT IT WAS READING HIS BG AT 100-114 WHICH WOULD AUTOMATICALLY REDUCE THE INSULIN HIS PUMP PROVIDES HIM. IT WAS NOT UNTIL THIS MORNING THAT WE DISCOVERED THAT HIS BG WAS ACTUALLY 256 BY FINGER STICK AND HAD BEEN DRIVEN UP BY THE REDUCTION OF INSULIN DUE TO INACCURATE INFORMATION FROM THE G7. THIS IS ESPECIALLY FRIGHTENING WHEN CONSIDERING IF IT HAD BEEN ERRONEOUSLY READING TOO HIGH THE PUMP, RESPONDING TO THAT, COULD HAVE GIVEN HIM A POTENTIALLY LETHAL DOSE OF INSULIN IN HIS SLEEP. EVEN WITH OUR RECOGNIZING THIS ISSUE'S FREQUENCY, WE CANNOT MAKE A PLAN TO CHANGE THE G7 AT 8 OR 9 DAYS THUS MINIMIZING THIS RISK. THE REASON WE CANNOT PLAN TO CHANGE EARLY IS BECAUSE AS LONG AS DEXCOM MAINTAINS THAT THE G7 LASTS 10 DAYS INSURANCE PLANS AND MEDICARE WILL NOT AUTHORIZE MORE THAN 3 DEVICES PER MONTH. EARLY CHANGES WOULD RESULT IN AN INSUFFICIENT NUMBER OF SENSORS TO LAST TO THE NEXT AUTHORIZED REFILL. DEXCOM'S WARRANTY REPLACEMENT WILL ONLY COVER REPLACEMENT OF A SENSOR THAT HAS ALREADY FAILED, NOT ONE THAT WAS CHANGED PROACTIVELY TO AVOID RISK TO LIFE. IF DEXCOM CANNOT CORRECT THE 10-DAY ISSUE, EITHER BY CORRECTION OF THE PRODUCT OR REDUCTION OF THE LASTING DURATION, THEY SHOULD NOT BE ALLOWED FDA APPROVAL TO BE USED IN A DEPENDENT INTERACTION WITH AN INSULIN PUMP, IN OUR CASE A TANDEM T-SLIM X2. THIS IS NOT JUST ABOUT A CONSISTENT PRODUCT FAILURE. THEIR POSSIBLE MISREPRESENTATION AND POTENTIAL LACK OF QUALITY CONTROL, IF ALLOWED TO CONTINUE ESPECIALLY IN DEPENDENT CONJUNCTION WITH AN INSULIN PUMP, POSES A SERIOUS RISK TO HEALTH AND LIFE THAT THEY ARE FAILING TO ADDRESS AND ACT UPON.