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U.S. Department of Health and Human Services

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

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DEXCOM, INC. 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 10/30/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of death.
 
Event Description
Dexcom was made aware on 11/17/2016 that on (b)(6) 2016, that the patient passed away. Patient's wife reported that the patient passed away at home due to cardiac arrest. Emergency medical technicians (emts) arrived and the patient's body was transported to a hospital. 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. No product or data was provided for evaluation. The customer complaint could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A receiver (part number stk-gf-001/serial number (b)(4)/lot number 5220275) was returned for evaluation. A visual inspection was performed and no defects were found. Functional testing was performed and no failures were detected. A review of the data log did not find any errors. Additionally, a transmitter (part number stt-gf-001/serial number (b)(4)/lot number 5216445) was returned for evaluation. A visual inspection was performed and no defects were found. Functional texting and a pairing test was performed and the tests passed. The devices were determined to be operating within the required specifications without malfunction. There was no allegations to the devices.
 
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Brand NameNI
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
8582000200
MDR Report Key6153324
MDR Text Key61693141
Report Number3004753838-2016-52895
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 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
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 Received12/30/2016
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: 12/07/2016 Patient Sequence Number: 1
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