MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	N/A
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.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 determined to be the mobile device lost power.No injury or medical intervention was reported.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 11042195
• Report Number: 3004753838-2020-157119
• Device Sequence Number: 16399873
• Product Code: PQF
• UDI-Device Identifier: 00386270000002
• UDI-Public: 00386270000002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: SW10611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 81