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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Caustic/Chemical Burns (2549)

Event Date 09/09/2020

Event Type  Injury  

Event Description

Experienced chemical burns from dexcom g6 adhesive pads.Skin under the adhesive pad began itching, then discharging yellow liquid, then bleeding.Had to remove dexcom g6 device prior to 10 day indicated wear period.Fda safety report id# (b)(4).

Event Description

Additional info received from reporter on 12/30/2020 for mw5098608.Experienced chemical burns from dexcom g6 adhesive pads.Skin under the adhesive pad began itching, then discharging yellow liquid, then bleeding.Had to remove dexcom g6 device prior to 10 day indicated wear period.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11100706
• MDR Text Key: 224810763
• Report Number: MW5098608
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 5279384
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 79