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

Model Number MT20649-1

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that unexpected receiver shut-down occurred. no product or data was provided for evaluation.Confirmation of the allegation and a root cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.The device was externally visually inspected and it passed.The receiver failed to charge and reboot, the receiver vibrated in three bursts.The receiver log download and functional testing were unable to be performed due to the receiver vibrating in three bursts.The receiver case was opened and the internal inspection passed.The battery was removed and replaced, it still failed to turn on due to vibrating in three bursts.Confirmation of the allegation and 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: 8502039
• MDR Text Key: 141591632
• Report Number: 3004753838-2019-33544
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/10/2019

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: MT20649-1
• Device Catalogue Number: STK-GL-010
• Device Lot Number: 5234985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2017
• 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: 65 YR
• Patient Weight: 81