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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC.

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DEXCOM, INC. Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Swelling (2091); Cancer (3262)
Event Date 03/31/2017
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 05/16/2017, that the patient passed away on (b)(6) 2017. On (b)(6) 2017, the patient went to the hospital due to leg swelling. A computed tomography (ct) scan was performed and metastatic cancer was found in the patient's abdomen. The patient was diagnosed with cancer the same day. The patient spent approximately three weeks in the hospital. The patient was transferred to hospice care on (b)(6) 2017. The patient passed away on (b)(6) 2017. It was reported that the patient's cause of death was metastatic cancer. It was indicated that the patient was on medications for blood pressure and gout. It was reported that the patient was only using the dexcom system for four days until he passed away. There was no alleged device malfunction. Patient's wife contacted dexcom to cancel supplies. A certificate of death was not provided. No additional event or patient information is available.
 
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Brand NameNA
Type of DeviceNA
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 Key6611060
MDR Text Key76654902
Report Number3004753838-2017-47741
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 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received05/16/2017
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: 06/05/2017 Patient Sequence Number: 1
Treatment
BLOOD PRESSURE MEDICATION; GOUT MEDICATION; INSULIN
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