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

Model Number	MT22495-PNK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2017
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, an error icon was displayed on the receiver.Data was not available for evaluation.Confirmation of the error icon and a probable cause could not be determined.No additional event or patient information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The receiver was received for evaluation.An external visual inspection was performed and the receiver passed.A charging and boot up test was performed and the receiver failed as the error was observed on the display.The probable cause could not be determined.
Additional Manufacturer Narrative
(b)(4).

• 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: 7210949
• Report Number: 3004753838-2018-007978
• Device Sequence Number: 11052367
• Product Code: MDS
• UDI-Device Identifier: 20386270000167
• UDI-Public: 20386270000167
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2017

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: MT22495-PNK
• Device Catalogue Number: STK-RR-PNK
• Device Lot Number: 5219359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 12/23/2017
• Supplement Date Received by Manufacturer: 02/16/2018; 02/16/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/16/2018; 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR