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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. N/I CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. N/I CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 10/08/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of microvascular complications and death.
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, that the patient passed away. Patient's father reported that on (b)(6) 2016, the patient was experiencing chest pains. The patient's cousin called emergency medical technicians (emts). Emts arrived at approximately 6:00 pm, but not transport patient to a health facility. Approximately two (2) hours later the cousin checked on the patient that he thought was sleeping, but the patient was unresponsive. Patient's cousin called emts again. The emts arrived and pronounced the patient dead at the time of their arrival, approximately 9:00 pm. Patient's body was transported to a medical center. A copy of the 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. Additional event or patient information is not available.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameN/I
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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
8585000200
MDR Report Key6146541
MDR Text Key61491117
Report Number3004753838-2016-52924
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
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 Received11/14/2016
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 Initial

Patient Treatment Data
Date Received: 12/05/2016 Patient Sequence Number: 1
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