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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 09/04/2021

Event Type  Injury  

Event Description

Dexcom g6 left severe burn like marks on arm where it had been applied.Issue was repeated with the next 2 sensors as well.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12475364
• MDR Text Key: 271930314
• Report Number: MW5103952
• 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: Unknown
• Type of Report: Initial
• Report Date: 09/13/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 77