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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 Cardiac Arrest (1762); Death (1802); Ischemic Heart Disease (2493)
Event Date 03/21/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of death.
 
Event Description
Patient's doctor's office contacted dexcom on (b)(6) 2016 to report that the patient passed away. Dexcom made contact with the patient's wife, who reported that on (b)(6) 2016, the patient was at his granddaughter's soccer game when he experienced shortness of breath and seized up. 911 was called and the patient was transported to the hospital, where he passed away. The cause of death was reported as asystole, cardiorespiratory arrest and coronary artery disease. A certificate of death was not provided. Patient was wearing the continuous glucose monitor at the time of death, however, there was no alleged device malfunction. Additional event or patient information was not provided.
 
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Brand NameNI
Type of DeviceMDS
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 Key5602254
MDR Text Key43433261
Report Number3004753838-2016-02524
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 03/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
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 Received03/24/2016
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

Patient Treatment Data
Date Received: 04/22/2016 Patient Sequence Number: 1
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