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

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 11/07/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause death.

Event Description

Dexcom was made aware on 11/28/2016, that on (b)(6) 2016, the patient had passed away.The patient's wife stated that the patient went to hospital three weeks ago for issues with breathing and kidney failure.He was not wearing his continuous glucose monitor (cgm) while in hospital and he passed away on (b)(6) 2016 at 7:29am.From heart failure.There is no allegation against the dexcom system per patient's wife.The date of invention is an approximate date.No product defects or failures were alleged.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 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: 6204574
• MDR Text Key: 63263535
• Report Number: 3004753838-2016-88451
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NA(241)NA(10)NA(17)NA
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICATION; WATER PILL
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 167