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

Catalog Number UNKNOWN

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

Patient Problems Death (1802); Pneumonia (2011); Loss of consciousness (2418)

Event Date 01/29/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2016, to report a patient death that occurred on (b)(6) 2016.Patient was not wearing dexcom continuous glucose monitor (cgm) at the time of the reported event.Patient's father came home on friday, (b)(6) 2016, and went to check on the patient who was sleeping on the couch.Patient was unresponsive and patient's father called 911.Emergency medical technician's (emt) arrived and transported the patient to the hospital.It was reported that doctors originally thought that the cause of death was septic shock.It was reported that after autopsy, it was confirmed that the cause of death was pneumonia.Additionally, it was reported that the patient was currently taking several medications at the time of the reported event.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.It was reported that the patient expired as a result of pneumonia.However, a conclusive root cause cannot be determined without a certificate of death.

• Brand Name: DEXCOM G4 PLATINUM 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: 5462024
• MDR Text Key: 39077134
• Report Number: 3004753838-2016-01351
• 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: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• 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: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 26 YR
• Patient Weight: 64