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

Model Number	9438-05
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that transmitter failed error occurred.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that transmitter failed error occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage test was performed and failed due to 0 v.Data was received but does not reflect full investigation window.Confirmation of the allegation could not be determined.A probable cause could not be determined as the allegation was not found.No injury or medical intervention was reported.

• 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: 10988203
• Report Number: 3004753838-2020-153800
• Device Sequence Number: 17015875
• Product Code: MDS
• UDI-Device Identifier: 00386270000125
• UDI-Public: 00386270000125
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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 Expiration Date: 10/27/2020
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-004
• Device Lot Number: 5271888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1