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

Catalog Number SW10611

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, a loss of connection between the transmitter and smart device occurred.No additional patient or event information is available.Data was provided for evaluation.Data review confirmed the reported event of a loss of connection.A root cause could not be determined via data.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6216467
• MDR Text Key: 63690020
• Report Number: 3004753838-2016-94613
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000002
• UDI-Public: (01)00386270000002(241)NA(10)NA(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2016

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 Catalogue Number: SW10611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/30/2016
• 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: 63 YR
• Patient Weight: 68