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

Model Number MT22608-PNK

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

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.The receiver was returned for evaluation.An exterior visual inspection was performed and passed.A charge and boot test was performed and the receiver failed to charge.The receiver was observed to become unusually hot during the charging test.The receiver log was downloaded and reviewed, and errors relevant to the customer complaint were found in the investigation window.Functional testing was performed and the receiver failed the initial battery test.The receiver was opened for further investigation.An internal visual inspection was performed and passed.The receiver was plugged into a charging source and the u5 main board was observed to become unusually hot during charging.The customer complaint of the overheating of the receiver was confirmed.The probable cause was determined to be a defective u5 main board.

• 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: 7233101
• MDR Text Key: 98763052
• Report Number: 3004753838-2018-011120
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000191
• UDI-Public: 10386270000191
• 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
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22608-PNK
• Device Catalogue Number: STK-PR-PNK
• Device Lot Number: 5220790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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: 10 YR
• Patient Weight: 36