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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 Death (1802); Ulcer (2274); Blood Loss (2597)
Event Date 02/20/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of death.
Event Description
Patient's son-in-law contacted dexcom on (b)(6) 2016 to report that the patient passed away on (b)(6) 2016. On (b)(6) 2016 the patient had some kind of rupture from an ulcer and their blood sugar kept increasing, as a side effect. The patient's granddaughter called the ambulance and the patient was taken to the hospital. Patient's blood loss could not be stopped and the patient died from internal bleeding on (b)(6) 2016 while at the hospital. Patient was wearing the cgm system at the time of the event. There was no alleged device malfunction. A death certificate was not provided and the cause of death could not be confirmed. No additional event or patient information is available.
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Brand NameNI
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 Key5515278
MDR Text Key40830024
Report Number3004753838-2016-01786
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 02/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2016
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 Received02/22/2016
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: 03/21/2016 Patient Sequence Number: 1