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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a seizure due to low blood glucose. The patient's brother came home and found the patient incoherent, called the paramedics and gave the patient honey. By the time the paramedics arrived, the patient's blood glucose was at 76mg/dl. No medication was administered by the paramedics and the patient was not transported to the hospital. Patient's father reported that they were not alerted to the low event due to the transmitter serial number not being entered into the g5 mobile application or their receiver. There was no alleged device malfunction. At the time of contact, the patient was doing well. Additional event or patient information is not available. No product or data was provided for evaluation. The reported low event could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
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 Key6072577
MDR Text Key58985572
Report Number3004753838-2016-80779
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
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
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 Received10/07/2016
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 Unkown

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
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