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

Model Number	MT20649
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a unexpected receiver shut-down occurred.No product or data was provided for evaluation.Confirmation of the allegation and a root cause could not be determined.No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM PROFESSIONAL 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: 8843331
• Report Number: 3004753838-2019-56847
• Device Sequence Number: 10845000
• Product Code: MDS
• UDI-Device Identifier: 40386270000062
• UDI-Public: 40386270000062
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/30/2019

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: MT20649
• Device Catalogue Number: STK-PU-001
• Device Lot Number: 5237217
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66