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

Model Number MT20649-1

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted.(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver shutdown unexpectedly.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver ceasing to function could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.The device was externally visually inspected and it passed.The receiver failed to charge and reboot.The receiver did not turn on.The battery was replaced with a known good battery and the receiver turned on.The log was downloaded, there was no data within the investigation window.The receiver case was opened, the internal inspection passed.The battery was inspected and it failed due to low voltage.Confirmation of the allegation and a root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: ying chen ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8182924
• MDR Text Key: 131048450
• Report Number: 3004753838-2018-159381
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STK-GL-010
• Device Lot Number: 5223319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 81