MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	MT22495-BLU
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver displayed a "call tech support" error.No additional patient or event information is available.The receiver has been received for device investigation.A follow-up report will be submitted upon completion of device investigation.
Additional Manufacturer Narrative
(b)(4).Describe event or problem - additional.Device available for evaluation - additional.Additional information/device evaluation.Device evaluated by manufacturer - additional.Event problem and evaluation codes - additional.
Event or Problem Description
The receiver was returned for evaluation.An external visual inspection was performed and passed.The receiver data log could not be downloaded, but a "call tech support" error was observed and pictures were taken.The reported event of an error icon display was confirmed due to the occurrence of a "call tech support" error.A probable cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM 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: 7318888
• Report Number: 3004753838-2018-022822
• Device Sequence Number: 16558125
• Product Code: MDS
• UDI-Device Identifier: 20386270000174
• UDI-Public: 20386270000174
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2018

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: MT22495-BLU
• Device Catalogue Number: STK-RR-BLU
• Device Lot Number: 5220683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/10/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR