MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR 3'S; SENSOR, GLUCOSE, INVASIVE

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Sensor last 4 days and stopped working.

• Brand Name: DEXCOM G6 SENSOR 3'S
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12354118
• MDR Text Key: 268033678
• Report Number: MW5103413
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 08627005303
• UDI-Public: 08627005303
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR