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

Model Number MT20649-2

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver shutdown unexpectedly.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.An external visual inspection was performed and failed.The receiver failed to charge and boot up due to usb pin(s) from j3 are damaged.The receiver download failed to retrieve and attach.The functional test could not be performed due to receiver could not boot up and\or communicate with tester.The receiver case was opened, and the internal inspection passed.The allegation was undetermined.The 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 CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego, ca CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence drive; san diego, ca, CA 92121 ; 8582000200
• MDR Report Key: 8547570
• MDR Text Key: 143745292
• Report Number: 3004753838-2019-36823
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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-117
• Device Lot Number: 5234969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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