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

Model Number	MT20649
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
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 the receiver had intermittent audio output.No additional event or patient information is available.The receiver has been received for evaluation.  a follow-up report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Receiver was charged and booted up.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.Global communication tool software test was performed and passed.A review of the downloaded data log did not find any errors related to the customer complaint.A manual test was performed and speaker sounded.A manual drop test for intermittency was performed and the test passed.The receiver case was opened for further evaluation.A visual interior inspection was performed and the inspection passed.A speaker resistance test was performed and passed.The device was determined to be operating within the required specifications without malfunction.The reported event of an intermittent audio output was not confirmed.A 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: 6794516
• Report Number: 3004753838-2017-63957
• Device Sequence Number: 131653
• Product Code: PQF
• UDI-Device Identifier: 30386270000065
• UDI-Public: (01)30386270000065(241)STK-RX-001(10)5166444
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/24/2017

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: MT20649
• Device Catalogue Number: STK-RX-001
• Device Lot Number: 5166444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 91