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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 CONTINOUS GLUCOSE MONITOR
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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia, loss of consciousness and seizures. The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, an adverse event had occurred. The patient's mother stated that the patient was passing out and having a seizure while not wearing dexcom system. On (b)(6) 2017, the patient's mother found the patient sitting in a daze at 1:30am. The patient's mother did finger stick on the patient and it read 78mg/dl and gave the patient juice. The patient's mother then did new finger stick and it read 58mg/dl and found the patient was starting to convulse. The patient's mother gave the patient some more juice at which time the patient passed out. The patient's mother called 911 and administered a glucagon shot. The patient had seizure for 5 mins and back 15-20 mins after shot administered. The patient's mother stated that by the time paramedics arrived, the patient was already awake. The patient's mother did not take the patient to hospital but called the patient's doctor and spoke to doctor's nurse practitioner about the issue. At time of contact the patient's condition was doing fine. No additional event or patient information is available. No product defects or failures were alleged as the patient was not wearing her dexcom system at the time of event.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6459285
MDR Text Key71683233
Report Number3004753838-2017-26294
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 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
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 Received03/13/2017
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: 04/04/2017 Patient Sequence Number: 1
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