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

Model Number	MT22949
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
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 no audio output.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver having no audio output could not be determined.A probable cause could not be determined.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The receiver was returned for evaluation.An exterior visual inspection was performed and passed.The receiver was charged and will boot.The receiver log was downloaded and reviewed, finding no errors related to the complaint.A global receiver functional test was performed, and it passed the speaker tests.A global communication tool software test was performed, and it passed sound tests.Manual "try it" testing and was performed and passed.The reported event of no audio output was not confirmed.A probable 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 dr.; san diego CA 92121
• MDR Report Key: 7215475
• Report Number: 3004753838-2018-008697
• Device Sequence Number: 16401064
• Product Code: PQF
• UDI-Device Identifier: 30386270000324
• UDI-Public: 30386270000324
• 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): 12/29/2017

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: STR-SD-001
• Device Lot Number: 5232705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR