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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Catalog Number SW10611
Device Problem Wireless Communication Problem (3283)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 03/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report a loss of connection and an adverse event that occurred on (b)(6) 2016. Patient's device was showing signal loss and during that time, he had a hypoglycemic seizure. Patient also experienced loss of consciousness. During the time of the event, the patient was at a restaurant with his wife and the paramedics were called. The patient was taken to the hospital and placed on an iv. Patient was at the hospital for about 3 hours and was discharged. Patient stated that when he got out of the hospital the device was working again. At the time of contact, the patient reported having headaches, cramps in the legs and being mentally fuzzy.
 
Manufacturer Narrative
(b)(4) describe event or problem - additional, additional information, event problem and evaluation codes - additional.
 
Event Description
Data was received from the patient. A review of the data log confirmed the reported event of a loss of connection. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5610222
MDR Text Key43713167
Report Number3004753838-2016-02810
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSW10611
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 Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2016 Patient Sequence Number: 1
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