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 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2019 that on (b)(6) 2019 the receiver ceased to function.No additional event or patient information is available.No product or data was provided for evaluation.The confirmation of the complaint is undetermined.The probable cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint states the receiver ceased to function.The product was evaluated.An external visual inspection was performed and passed.Charge and boot testing was performed and passed.The log was downloaded and reviewed finding no errors related to the complaint.Receiver functional test was performed and passed.The receiver was opened and an internal visual inspection was performed and passed.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, a correction is required.

• 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: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8367950
• MDR Text Key: 137081138
• Report Number: 3004753838-2019-021153
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5230566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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: 49 YR