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

Model Number MT22608-BLU

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

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 was charged and booted, but overheats when charging. Functional testing failed due to battery not charging past 30% after three hours of charging. The receiver case was opened for an internal visual inspection and it passed. The battery was replaced with a known good battery and receiver charges and turns on without overheating (discharged known good battery to 83%; charged known good battery from 83% to 100% in <30 minutes without overheating). The receiver log was downloaded and contains "rttloss" events related to complaint. The reported event of overheating or shocking device was confirmed. The root cause was determined to be a defective lithium ion battery.

• 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: 6720302
• Report Number: 3004753838-2017-57740
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000207
• UDI-Public: (01)10386270000207(241)STK-PR-BLU(10)5205000
• 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

• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MT22608-BLU
• Device Catalogue Number: STK-PR-BLU
• Device Lot Number: 5205000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Weight: 64