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

Model Number	MT22719
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted: (b)(4).
Event or Problem Description
Dexcom was made aware on 10/31/2017 that on (b)(6) 2017 the receiver ceased to function.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver ceased to function could not be determined.A root cause could not be determined.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was returned for evaluation.The device was visually inspected and no defects were found.The receiver will boot and charge.Perform manual test using the "try it" function: fail.Global receiver tool sound test: fail.Perform wiggle test: fail.Receiver functional test: fail.Open receiver for internal inspection: fail.Download log and finding relevant issues: pass.The complaint was confirmed because there were no audio heard.He reported event of no audio output was confirmed.The root cause was determined to be a defective speaker.

• 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: 7053260
• Report Number: 3004753838-2017-99134
• Device Sequence Number: 19099770
• Product Code: PQF
• UDI-Device Identifier: 00386270000231
• UDI-Public: 00386270000231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: MT22719
• Device Catalogue Number: STK-GF-IUO
• Device Lot Number: 5216913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1