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

Device Problems Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2020

Event Type  malfunction  

Event Description

A reporter called to report that he is having issues with his dexcom g6 glucose monitor and sensors.He said the monitor is not communicating with the sensors as a result it is not doing what it is supposed to do.He said sometimes the battery shuts down and the sensors only lasts for 2-1/2 to 3 days instead of the 10 days.He contacted dexcom every time he was encountering problems, however, they just keep sending him a replacement instead of addressing the issues.He said so far he had 8 or 9 replacements.

• Brand Name: SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11261931
• MDR Text Key: 230091571
• Report Number: MW5099125
• Device Sequence Number: 3
• 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
• Report Date: 01/29/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 86