MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Blister (4537)

Event Date 11/01/2020

Event Type  Injury  

Event Description

I developed a severe skin rash including redness, etching and blistering from adhesive from dexcom sensor.I had been using the product previously without any issue.When i called i have reported this issue to my endocrinologist and np.My np reports many patients with this same issue.This is a consumable device replaced every 10 days.The dexcom support line regarding the issue the customer rep did tell me that there had been a change in the adhesive used.I have no other skin sensitivities.Dexcom chat lines indicate many users of the product with the current adhesive are having issues with the new adhesive.Despite using skin-prep, tegaderm barriers and a steroid spray, the problem persists.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 13025821
• MDR Text Key: 282584169
• Report Number: MW5106133
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81MG QOD; CENTRUM SILVER TAB QD; CITALOPRAM 10 MG QOD; CITRACAL 'NET D" 250-200 MG TABLET ; DICLOFENAC 75MG EC PRN; GLUCAGON 1MG "KCT" PRN; GREEN TEA; INALAPRIL 5 MG QD; LEVOTHYROXINE 50MG QD; NOVOLOG 40-50 UNITS TDD VIA PUMP; SPINEPHRINE 0.3 MG/ML PEN PRN ; TANDEM T-SLIM PUMP ; TRIAMCINOLONE OINMENT 0.17% PRN ; VIT D3 5000 IU QD
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White