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

Model Number	MT22608-BLU
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2019, that on (b)(6) 2019, a loss of connection occurred.No product or data was provided for evaluation.Confirmation of the reported allegation was undetermined.The probable cause could not be determined.No additional event or patient information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial report, additional information became available.The receiver was returned for evaluation.The following were performed: external visual inspection, receiver charge and boot, final functional test and the data file was reviewed.The reported allegation was not confirmed.The probable cause could not be determined post investigation.

• 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: 8291381
• Report Number: 3004753838-2019-13682
• Device Sequence Number: 1991181
• Product Code: MDS
• UDI-Device Identifier: 10386270000207
• UDI-Public: 10386270000207
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/15/2019

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: MT22608-BLU
• Device Catalogue Number: STK-PR-BLU
• Device Lot Number: 5231388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 23