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

Model Number MT22495

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that unexpected receiver shutdown occurred. No product or data was provided for evaluation. Confirmation of the allegation and a probable 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 passed. A receiver charge and boot test was performed and failed due to rx unit not booting up and\or communicating. An internal visual inspection was performed and failed due to moisture damage. Pictures were taken. The log was not downloaded for review due to rx unit not booting up and\or communicating. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ying chen ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8915135
• MDR Text Key: 155050692
• Report Number: 3004753838-2019-061186
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5253445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial