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

Model Number	MT22949
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, a loss of connection between the transmitter and receiver occurred.No additional patient or event information is available.The receiver has been received for evaluation.A follow up report will be submitted once the evaluation has been completed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was returned for evaluation.An external visual inspection was performed and no defects were found.The receiver will boot and charge.The download log shows multiple screen out of range alarms and no antenna all within the incident date.Run receiver functional test.Pass, the reported event of loss of connection was confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 7136750
• Report Number: 3004753838-2017-113897
• Device Sequence Number: 11085230
• Product Code: PQF
• UDI-Device Identifier: 20386270000327
• UDI-Public: 20386270000327
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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: MT22949
• Device Catalogue Number: STK-SR-001
• Device Lot Number: DX73802103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR