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

Model Number MT20649-2

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

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.The device has been received for evaluation.  a follow-up report will be submitted once the evaluation is complete.

Manufacturer Narrative

(b)(4).

Event Description

The complaint receiver device was returned for evaluation.An external visual inspection was performed it passed.The receiver failed to charge and reboot.Receiver log was not available for download.Functional testing could not be performed.The receiver case was opened for further evaluation.An interior inspection found the moisture detection sticker activated.Due to moisture damage, the reported event of an overheating receiver was confirmed.The root cause was determined to be moisture damage.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.The receiver was charged and would not boot.Functional testing and data download were unable to be performed.The receiver case was opened for further evaluation.A visual interior inspection was performed and found that the moisture detection sticker was activated.The complaint confirmation was unable to be determined.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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6807348
• MDR Text Key: 83138838
• Report Number: 3004753838-2017-67847
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/31/2017

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: MT20649-2
• Device Catalogue Number: STK-GL-113
• Device Lot Number: 5219511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 08/11/2017; 10/24/2017
• Supplement Dates FDA Received: 09/08/2017; 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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: 51 YR
• Patient Weight: 82