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

Model Number	MT22719-PNK
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2017
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 initialized without a manual restart.No additional event or patient information is available.Data was received but further investigation cannot be performed to confirm the problem and determine the root cause of the reported issue.No product was provided for evaluation.The complaint confirmation of the receiver initializing without manual restart could not be determined.A root cause could not be determined.
Additional Manufacturer Narrative
(b)(4).Describe event or problem - additional.Device availability- additional.Additional information/device evaluation.Device evaluated by manufacturer - additional.Event problem and evaluation codes - additional.
Event or Problem Description
The complaint receiver device was returned for evaluation.The device was visually inspected and no defect was found.The receiver was charged and was perpetually rebooting.The receiver was opened and the ui pcba was detached to perform a download.The receiver log was reviewed, there was no data within the investigation window.Functional testing was unable to be performed.The reported event of initializing screen without manual restart could not be determined.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: 7187266
• Report Number: 3004753838-2018-04943
• Device Sequence Number: 1951913
• Product Code: PQF
• UDI-Device Identifier: 30386270000263
• UDI-Public: 30386270000263
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/19/2017

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-PNK
• Device Catalogue Number: STK-GF-PNK
• Device Lot Number: 5223623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR