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

Catalog Number STS-OE-003

Device Problem Product Quality Problem (1506)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Discoloration (2074); Discharge (2225); Skin Inflammation (2443)

Event Date 09/13/2020

Event Type  Injury  

Event Description

Dexcom g6 sensor adhesive causing allergic skin reaction.Dexcom switched the sensor adhesive manufacturing in the early part of 2020, and i have had an allergic reaction even since.Blistering , redness, puss and inflammation.Takes several weeks to heal.I have tried several opsite barriers per my doctor's recommendation, but they have not prevented the rash from presenting.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10540858
• MDR Text Key: 207358639
• Report Number: MW5096667
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2021
• Device Catalogue Number: STS-OE-003
• Device Lot Number: 7277590
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 61