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

Model Number MT20649-3

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver display was frozen.Data was received but not investigated as data will not confirm the issue.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Event Description

Subsequent to the initial mdr, a correction is required.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.An external visual inspection was performed and passed.Receiver charge and boot tests were performed and passed.Functional test were performed and passed.A receiver manual buttons test was performed and passed.The receiver log was downloaded and reviewed finding no error related to the complaint.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Event Description

Subsequent to the initial mdr, a correction and additional information is required.

Manufacturer Narrative

(b)(4).

• 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
• MDR Report Key: 11826409
• MDR Text Key: 250687939
• Report Number: 3004753838-2021-87376
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-3
• Device Catalogue Number: STK-JP-019
• Device Lot Number: 5268183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1