MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 TRANSMITTER; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR PROFESSIONAL DIRECTED RETROS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Patient deceased.Pae(prostate artery embolization) reported by hcp(healthcare personnel), who does not consent to follow up.(b)(4).

• Brand Name: DEXCOM G6 TRANSMITTER
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR PROFESSIONAL DIRECTED RETROS
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 16630088
• MDR Text Key: 312201916
• Report Number: MW5116030
• Device Sequence Number: 1
• Product Code: QII
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Death