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

Model Number	MT22949
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
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 displayed an error message of not receiving glucose readings.No additional event or patient information is available.No product or data were provided for evaluation.The confirmation of the complaint is undetermined.A root cause could not be determined.
Additional Manufacturer Narrative
Com-(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint receiver was returned for evaluation.The device was visually inspected and no defect was found.The receiver will boot and charge.The receiver download was retrieved and no issues were found.Receiver functional tester: passed all relevant testing.The reported event was not confirmed via product.A probable cause could not be determined via product.

• 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: 7203939
• Report Number: 3004753838-2018-006968
• Device Sequence Number: 19013332
• Product Code: PQF
• UDI-Device Identifier: 30386270000324
• UDI-Public: 30386270000324
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/01/2018

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: 5231990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/27/2018; 04/27/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 03/29/2018; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR