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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
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.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5462024
MDR Text Key39077134
Report Number3004753838-2016-01351
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 other
Reporter Occupation
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 Received02/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received02/02/2016
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 Initial

Patient Treatment Data
Date Received: 02/25/2016 Patient Sequence Number: 1
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