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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. MDS

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DEXCOM, INC. MDS Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Sudden Cardiac Death (2510)
Event Date 06/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of death.
Event Description
Patient's wife contacted dexcom on (b)(6) 2016 to report that the patient passed away on (b)(6) 2016. The patient's wife stated that the patient was admitted to the hospital on (b)(6) 2016 for a fever and infection of his artificial aortic valve. The patient was wearing dexcom when he was admitted and then at the hospital it was removed. On the (b)(6) 2016 the patient passed away from cardiac arrest. There was no alleged device malfunction. A certificate of death was not provided. No further event or patient information is available.
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Brand NameNA
Type of DeviceMDS
Manufacturer (Section D)
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
MDR Report Key5818173
MDR Text Key50288035
Report Number3004753838-2016-38895
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 06/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2016
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 Received06/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/24/2016 Patient Sequence Number: 1