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

Model Number N/A

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

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 could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).Initially this event was reported as a reportable malfunction.Upon further review it was determined that this event does not meet the criteria of a reportable complaint.Mfr 3004753838-2020 -037019 was reported in error.Please disregard initial reporting of this event since this has now been deemed non-reportable.

Event Description

Subsequent to the initial mdr, it was determined that the report was submitted in error.(b)(4) did not occur and therefore the criteria of a reportable complaint is not met as per the code of federal regulations.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.It was determined that loss of connection was related to the mobile application.It was indicated that the operating system for the smart device was not a supported system, which is off-label usage of the device.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).3004753838-2020-037019 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.

Event Description

Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.

• Brand Name: DEXCOM G6 GLUCOSE PROGRAM 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: 9979538
• MDR Text Key: 188323920
• Report Number: 3004753838-2020-037019
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182041
• 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,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: SW11785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• 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: 72 YR
• Patient Sex: Male