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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 Gangrene (1873); Heart Failure (2206); Cancer (3262)
Event Date 01/15/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of death.
 
Event Description
Patient's wife contacted dexcom on 04/19/2016 to report that the patient passed away on (b)(6) 2016. It was stated that the patient had been a diabetic for over 65 years and several health problems, including cardiac issues as well as cancer. The patient had developed gangrene in his feet and was admitted to the hospital in (b)(6), approximately (b)(6) 2016, for the amputation of both legs. Patient was later transferred to a rehabilitation center where he stayed until his passing. Patient's wife reported the causes of death as heart failure, cancer and diabetes. A certificate of death was not provided. The patient was not wearing the continuous glucose monitor (cgm) at the time of death. There was no alleged device malfunction. No additional event or patient information was 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 Key5658551
MDR Text Key45275523
Report Number3004753838-2016-03068
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 04/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2016
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 Received04/19/2016
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: 05/16/2016 Patient Sequence Number: 1
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