MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9445-20

Device Problem Wireless Communication Problem (3283)

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

Event Date 11/11/2023

Event Type  malfunction  

Event Description

The complaint states that signal loss over one hour was reported.No data or product was provided for investigation.The allegation was undetermined.The probable cause could not be determined.

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that signal loss over one hour occurred.It was determined that the signal loss was related to the mobile application.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.

Event Description

Correction to d4 fields.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G6 PROFESSIONAL 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: 18267184
• MDR Text Key: 329732215
• Report Number: 3004753838-2023-253263
• 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,Followup
• Report Date: 12/05/2023

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: Lay User/Patient
• Device Expiration Date: 02/27/2024
• Device Model Number: 9445-20
• Device Catalogue Number: STP-PR-001
• Device Lot Number: 5325643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 11/11/2023; 12/05/2023
• Supplement Dates FDA Received: 12/05/2023; 12/05/2023
• 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: 64 YR
• Patient Sex: Female