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

Model Number MT22495-PNK

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the receiver was overheating.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the overheating of the receiver could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint receiver device was returned for evaluation.An external visual inspection was performed and no defects were found.The receiver was charged and rebooted.The receiver log was downloaded, there was no data within the investigation window.Functional testing was performed and it passed.The receiver case was opened for an internal visual inspection and it passed.The reported event of an overheating device was undetermined.The root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7176529
• MDR Text Key: 96817893
• Report Number: 3004753838-2018-03326
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000160
• UDI-Public: 10386270000160
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-PNK
• Device Catalogue Number: STK-DR-PNK
• Device Lot Number: 5216947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• 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: 23 YR
• Patient Weight: 57