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

Model Number	9438-01
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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, a loss of connection occurred.No additional patient or event information is available.No product or data were provided for evaluation.The complaint confirmation of a loss of connection could not be determined.A root cause could not be determined.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Upon further review, this record has been determined to not be reportable based on confirmation that a loss of connection did not occur.Please disregard initial reporting under mfr# 3004753838-2019-09417.

• Brand Name: DEXCOM G4 PLATINUM PROFESSIONAL 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: 8259295
• Report Number: 3004753838-2019-09424
• Device Sequence Number: 19341601
• Product Code: MDS
• UDI-Device Identifier: 50386270000045
• UDI-Public: 50386270000045
• 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): 01/17/2019

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: 9438-01
• Device Catalogue Number: STT-PU-001
• Device Lot Number: 5237434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1