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

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Disorders (4543)

Event Date 09/12/2020

Event Type  Injury  

Event Description

I use a dexcom g6 to manage my blood sugar and base my insulin intake with my pump on the cgm's readings. There has recently been a new ingredient put in the adhesive of the g6 and i am having terrible allergic skin reactions. Fda safety report id# (b)(4).

• Brand Name: G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10829199
• MDR Text Key: 216184988
• Report Number: MW5097791
• 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: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 11/10/2020 Patient Sequence Number: 1