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

Model Number MT22495-BLU

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver was overheating.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the overheating of the receiver could not be determined.A probable cause could not be determined.

Manufacturer Narrative

Com-(b)(4).

Event Description

The receiver was returned for evaluation.An exterior visual inspection was performed and failed.The usb port connector was found to be contaminated.A charge of the unit was attempted and it failed to charge and boot.The data log was attempted to download, however could not be performed.The receiver case was opened for an interior inspection, and failed.The moisture damage was observed.The complaint was confirmed for receiver overheating due to a defective receiver u5.The probable cause was determined to be defective receiver u5.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7353383
• MDR Text Key: 102908388
• Report Number: 3004753838-2018-028401
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000177
• UDI-Public: 10386270000177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5222047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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: 38 YR