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

Catalog Number STK-JP-019

Device Problems Inappropriate or Unexpected Reset (2959); Unexpected Shutdown (4019)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver initialized without a manual restart 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.

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).

• 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: 11949291
• MDR Text Key: 254601933
• Report Number: 3004753838-2021-101039
• 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
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STK-JP-019
• Was Device Available for Evaluation?: No
• 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