MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number STP-PR-001

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Event Description

It was reported that signal loss over one hour occurred.A review of the share logs was performed and a loss of connection was not found within the investigation window.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 18895191
• MDR Text Key: 337560832
• Report Number: 3004753838-2024-060783
• Device Sequence Number: 1
• Product Code: QII
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STP-PR-001
• Device Lot Number: 5323076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male