FDA Adverse Event Injury Summary report: N

DEXCOM G7 SENSOR AND MOBILE APP

MDR report key: 20320996 · Received September 26, 2024

Report

Report Number
MW5160153
Event Type
Injury
Date Received
September 26, 2024
Date of Event
September 23, 2024
Report Date
September 23, 2024
Manufacturer
DEXCOM, INC.
Product Code
PJT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY MINOR CHILD WEARS A DEXCOM G7 SENSOR AS A CONTINUOUS GLUCOSE MONITOR TO MANAGE HER TYPE 1 DIABETES. THIS YEAR SHE HAS HAD SEVERAL SENSORS FAIL EARLY (THEY ARE NOT LASTING 10 DAYS). WHEN I TRIED TO GET A REPLACEMENT FOR THE FIRST FAILED SENSOR, I WAS DENIED A BONA FIDE REPLACEMENT AND INSTEAD SENT A "CURTESY" REPLACEMENT. WE WERE TOLD THAT IT WAS NOT A BONA FIDE REPLACEMENT BECAUSE SHE SHOULD HAVE WORN THE FAILED SENSOR FOR 3 HOURS BEFORE TAKING IT OFF. THIS PARTICULAR SENSOR FAILED EARLY IN THE MORNING, AND UPON HER WAKING UP THE DEXCOM APP DISPLAYED THE MESSAGE "SENSOR FAILURE - REMOVE SENSOR NOW". SINCE SHE WAS LEAVING FOR SCHOOL SHE CHANGED THE FAILED SENSOR FOR A NEW ONE. IT HAD BEEN ABOUT 2 HOURS SINCE THE LAST READING. DEXCOM SAID SHE SHOULD HAVE WAITED 3 HOURS BEFORE CHANGING THE SENSOR EVEN THOUGH THERE WAS A MESSAGE THAT SAID " SENSOR FAILURE - REMOVE SENSOR NOW". DEXCOM CUSTOMER SERVICE WAS TELLING ME WE SHOULD HAVE IGNORED THE MESSAGE ON THE APP TO CHANGE THE SENSOR AND SHOULD HAVE WAITED ANOTHER HOUR TO CHANGE OUT THE FAILED SENSOR - WHICH WOULD HAVE MEANT SENDING HER TO SCHOOL WEARING A FAILED SENSOR. DEXCOM STATED THAT BECAUSE WE DIDN'T WAIT THREE HOURS, THEY WOULD NOT SEND ME A BONA FIDE REPLACEMENT, BUT INSTEAD IT WOULD BE A "COURTESY" REPLACEMENT. THE SECOND SENSOR FAILURE THAT OCCURRED PRIOR TO THE 10 DAY EXPIRATION WAS ALSO NOT RECORDED AS A BONA FIDE FAILURE REPLACEMENT. THIS TIME SHE WAITED THREE HOURS BEFORE REPLACING IT. I REQUESTED A REPLACEMENT AND AGAIN I WAS TOLD THAT IT WAS NOT A BONA FIDE REPLACEMENT AND WOULD BE A COURTESY REPLACEMENT BECAUSE WE DID NOT HAVE THE OLD SENSOR SERIAL NUMBER IN THE APP. DEXCOM TOLD US THAT BECAUSE SHE HAD STARTED A NEW SENSOR AND SUPPOSEDLY WHEN STARTING A NEW SENSOR IT DELETES THE SERIAL NUMBER FROM THE OLD SENSOR IN THE APP. WE WERE TOLD IN THE FUTURE NOT TO START A NEW SENSOR UNTIL WE RETRIEVED THE SENSOR SERIAL NUMBER FROM THE APP. THE THIRD AND MOST RECENT SENSOR FAILURE JUST OCCURRED. THIS TIME SHE WAITED 3 HOURS AFTER THE SENSOR FAILURE AND DID NOT START A NEW SENSOR. INSTEAD WE CALLED DEXCOM TO LET THEM KNOW ABOUT THE FAILURE, CERTAIN THIS TIME IT WOULD BE A BONA FIDE REPLACEMENT. HOWEVER, WHEN WE WENT INTO THE APP TO GET THE SERIAL NUMBER IT WASN'T THERE. THIS TIME WE WERE TOLD BY DEXCOM THAT THE SERIAL NUMBER IS CLEARED IN THE APP WHEN THE SENSOR FAILS AND WE'D HAVE TO PROVIDE THE SERIAL NUMBER FROM THE BOX OR APPLICATOR. I TOLD DEXCOM IT HAS BEEN 8 DAYS AND WE DON'T KEEP TRASH FOR 8 DAYS. WE HAD PREVIOUSLY BEEN TOLD THE SERIAL NUMBER WOULD BE IN THE APP AND WERE RELYING ON THAT FOR THE SERIAL NUMBER. AGAIN, WE WERE ISSUED A "CURTESY" REPLACEMENT. WE'VE NOW REACHED OUR THIRD AND FINAL CURTESY REPLACEMENT IN JUST 4 MONTHS. SHE WILL HAVE TO GO 8 MORE MONTHS WITHOUT CURTESY REPLACEMENTS. WHEN THE FACT IS NONE OF THESE THREE REPLACEMENTS SHOULD HAVE BEEN CURTESY REPLACEMENTS. THEY WERE ALL BONA FIDE FAILURES THAT DEXCOM REFUSED TO ACKNOWLEDGE. THE ROOT OF MY CONCERN IS THAT I BELIEVE THAT DEXCOM IS BEING DECEPTIVE REGARDING THEIR REPORTING OF DEVICE FAILURES. THEIR APP ERASES THE SERIAL NUMBER THE MOMENT THE DEVICE FAILS, AND IF THE CONSUMER DID NOT RETAIN THEIR TRASH, THEN DEXCOM LOGS THE FAILURE AS "USER ERROR" SIMPLY FOR THE PATIENT NOT HAVING THE SERIAL NUMBER THAT THEIR OWN APP ERASES THE MOMENT A FAILURE OCCURS! THIS IS A DANGEROUS PRACTICE. WITHOUT ACCURATE RECORDING AND REPORTING OF FAILURES, DEXCOM IS NOT APPROPRIATELY TRACKING THEIR DEVICES FOR ISSUES. PATIENTS ARE WEARING DEVICES THAT ARE FAILING AND DEXCOM IS NOT RECORDING THESE AS DEVICE FAILURES, BUT INSTEAD AS "USER ERRORS". IN ADDITION, THERE IS THE CONSUMER PROTECTION VIOLATIONS BY THEM SELLING FAULTY DEVICES AND NOT REPLACING THEIR FAULTY DEVICES AND INSTEAD HARMING THE CONSUMER BY FORCING HER TO DO FREQUENT PAINFUL FINGER STICKS THROUGHOUT THE DAY BECAUSE SHE RAN OUT OF DEXCOM SENSOR THAT FAILED EARLY BECAUSE THEY WERE FAULTY/DEFECTIVE AND DEXCOM WOULD NOT OFFER REPLACEMENTS. REFERENCE REPORTS; MW5160154, MW5160155.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1052925 DEXCOM G7 SENSOR AND MOBILE APP CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY PJT DEXCOM, INC.

Patients

Seq Age Sex Outcome Treatment
1 16 YR Female Required Intervention MELATONIN| NOVOLOG INSULIN| TANDEM T SLIM X2 INSULIN PUMP