MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Catalog Number UNKNOWN

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 12/12/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Patient's son contacted dexcom on (b)(6) 2016, to report a patient death that occurred on (b)(6) 2015.Patient's wife called emergency medical technician's (emt).Patient was pronounced dead at the scene.Patient was not taken to the hospital.Patient was transported directly to the funeral home.Patient's son reported cause of death as cardiac arrest and reported another cause was listed as well, but he could not remember.Patient was not wearing dexcom continuous glucose monitor (cgm) at the time of death.Patient had just received the dexcom system and was waiting on a trainer to show him how to use it.No additional event or patient information is available.There was no alleged device malfunction.It should be noted that diabetes mellitus is a known cause of death.However, a conclusive root cause cannot be determined without a certificate of death.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5391198
• MDR Text Key: 36826456
• Report Number: 3004753838-2016-00678
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(17)NI
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• 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 Outcome(s): Death; Other
• Patient Age: 63 YR
• Patient Weight: 142