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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.It was indicated that the operating system for the smart device was not a supported system, which is off-label usage of the device.Data was provided for evaluation.(b)(4), cases where the sensor session line is missing in share support tool and share support service, complaints will be closed since a data investigation cannot be completed as data ambiguity cannot be resolved further.The allegation was undetermined.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

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.It was indicated that the operating system for the smart device was not a supported system, which is off-label usage of the device.Data was provided for evaluation.Per doc-00834, cases where the sensor session line is missing in share support tool and share support service, complaints will be closed since a data investigation cannot be completed as data ambiguity cannot be resolved further.The allegation was undetermined.The probable cause could not be determined.No injury or medical intervention was reported.

• 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: 11118582
• MDR Text Key: 225137617
• Report Number: 3004753838-2021-001137
• 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
• Report Date: 12/06/2021

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: 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
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 12/06/2021
• 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: 60 YR
• Patient Sex: Male