DEXCOM G6 CONSTANT GLUCOSE MONITOR
Received Feb 2, 2021 · Event occurred Nov 1, 2020
Report MW5099181 · MDR key 11272783
Device
Generic name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Manufacturer
Dexcom, Inc.Lot number
5278034
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
21 YR
- Rash
- Blister
- Rash
- Blister
Narrative
Description of Event or Problem
MY SON HAS BEEN USING THE DEXCOM CGM, G5 AND NOW G6, FOR THE LAST 2 PLUS YEARS WITHOUT ANY ADVERSE SIDE EFFECTS. STARTING IN NOVEMBER HE STARTED TO DEVELOP VERY BAD RASHES WITH SOME BLISTERING THAT REQUIRED TREATMENT WITH ANTIBIOTIC CREAM. I MADE CONTACT WITH DEXCOM AND WAS ADVISED THAT THEY HAD CHANGED A BINDING AGENT IN THE ADHESIVE AND THEY PROVIDED ME DIFFERENT THINGS TO TRY. WE FIRST TRIED SKINTAC, BARRIER WIPE. THIS DID NOT WORK AND THE RASH CONTINUED. WE THEN TRIED TEGADERM, BARRIER FILM. THAT ALSO DID NOT HELP WITH THE RASH. I SPOKE TO DEXCOM AGAIN AND THEY RECOMMENDED THAT WE TRY SPRAYING FLONASE ON THE SKIN FIRST AND IF THAT DIDN'T WORK, WE SHOULD USE A THICKER BARRIER FILM, DUODERM. MY SON TRIED FLONASE ALONE AND THAT DID NOT HELP THE RASH. FINALLY, HE IS NOW TRYING THE DUODERM PRODUCT. AS A TYPE 1 DIABETIC MY SON NEEDS HIS CGM TO APPROPRIATELY MONITOR HIS BLOOD SUGAR AND THE LOWS THAT CAN BE LIFE THREATENING. WE ARE LOOKING FOR ASSISTANCE AS HE HAD NO PROBLEM PRIOR TO THE CHANGE BY DEXCOM IN THEIR ADHESIVE FORMULA. FDA SAFETY REPORT ID # (B)(4).