inforMED
InjuryQBJ

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).