MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Discharge (2225); Impaired Healing (2378)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Have used the g5 and the g6 for a long time with zero reaction to my skin but they have changed the adhesive, and it now produces a severe chemical like burning rash that itches honorably and causes oozing welts that take weeks to heal.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G5
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10419785
• MDR Text Key: 203489335
• Report Number: MW5096102
• 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: 08/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 104