MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT22719-PNK

Device Problems Overheating of Device (1437); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Product code pqf is not currently available. .

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the receiver was overheating.No additional event or patient information is available.The receiver was not provided for evaluation.The reported event of the receiver overheating could not be confirmed.A root cause cannot be determined.It was reported that the operating system was worn during x-ray scanning at the airport.Labeling indicates: don't put your dexcom system components through x-ray machines.Before your screening process begins, ask the tsa officer to perform a visual inspection of the receiver and your extra sensors.Place all dexcom components in a separate bag before handing over to the security officer.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.An external visual inspection was performed and found crack on the display window.Functional testing was attempted but could not be performed because the receiver would not boot up; therefore, the data log could not be downloaded.The receiver case was opened for further evaluation and pass.Trouble shoot receiver circuitry and battery and passed.The u6 at the main board getting hot 160 degrees.The reported event of an overheating receiver was confirmed.A root cause was determined to be defective u6 at the main board.

• Brand Name: DEXCOM G5 MOBILE 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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6348369
• MDR Text Key: 67928494
• Report Number: 3004753838-2017-06745
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 20386270000263
• UDI-Public: (01)20386270000263(241)STK-GF-PNK(10)5206578
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719-PNK
• Device Catalogue Number: STK-GF-PNK
• Device Lot Number: 5206578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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: 42 YR
• Patient Weight: 89