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

Lot Number PICTURE INCLUDED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Peeling (1999); Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Chemical burn; dexcom g6 sensor, started a new batch early (b)(6), and started having reactions to the sensors after a couple of days.Tech support confirmed a change of adhesive in (b)(4) 2020.Reaction causes redness, itching, cracked skin, oozing, and peeling skin.Similar to reaction i had with early g4 sensors.Fda safety report id # (b)(4).

• Brand Name: G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10641932
• MDR Text Key: 210391765
• Report Number: MW5097116
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: PICTURE INCLUDED
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 142