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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC.; CONTINOUS GLUCOSE MONITOR
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DEXCOM, INC.; CONTINOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sudden Cardiac Death (2510)
Event Date 03/11/2017
Event Type  Death  
Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of death.
 
Event Description
Dexcom was made aware on 03/15/2017, that on (b)(6) 2017, the patient had passed away.The patient's wife stated that her husband had passed away due to cardiac arrest on (b)(6) 2017.The patient's wife stated that her husband's cardiac arrest was not due to his dexcom system.No product defects or failures were alleged.No death certificate was provided.No further patient or event information is available.
 
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Brand Name
NI
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 Key6478550
MDR Text Key72326169
Report Number3004753838-2017-26274
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 Other
Type of Report Initial
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
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
Date Manufacturer Received03/15/2017
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 Number1
Patient Outcome(s) Death;
Patient Age64 YR
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