MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a pair new transmitter message occurred.Data was evaluated and the allegation was confirmed as a pair new transmitter message was confirmed.The probable cause was determine to be a transmitter failed error.The reported event of a pair new transmitter message is reportable based on the finding of a transmitter failed error.No injury or medical intervention was reported.

• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 10170883
• MDR Text Key: 196209998
• Report Number: 3004753838-2020-060087
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR