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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Renal Failure (2041); Heart Failure (2206)
Event Date 05/22/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known contributer to microvascular complications.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient passed away due to renal failure. The patient's wife reported that on (b)(6) 2016, the patient was rushed to the hospital due to heart failure and renal failure. The patient had heart surgery- two stent procedures- and was placed on dialysis. Patient was then sent to a hospice and passed away on (b)(6) 2016. Patient was not wearing the continuous glucose monitoring (cgm) system at the time of passing as they had taken it off when admitted to the hospice. There was no alleged device malfunction. Report of death was initiated to close patient's account. Additional event or patient information is not available. No product or data was returned for investigation. A certificate of death was not provided. The reported death could not be confirmed. A root cause was not determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS 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 Key6145277
MDR Text Key61439740
Report Number3004753838-2016-52726
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/05/2016 Patient Sequence Number: 1
Treatment
COUMADIN; INSULIN; LASIX; STATIN
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