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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
Model Number MT22719-BLU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 05/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Patient's wife contacted dexcom on (b)(6) 2016 to report that the patient experienced a hypoglycemic event on (b)(6) 2016. Patient had seizure at about 3:30-3:40 central time. The patient's wife took the receiver out of the patient's pocket and saw that the continuous glucose monitor (cgm) displayed a value of 50mg/dl. Patient's wife reported a fingerstick value of between 50-60mg/dl. The patient had apple juice and then the ambulance came and gave him something. Patient's wife did not know what the emt's gave the patient. Fingerstick value was then 250mg/dl. The patient was taken to the hospital via ambulance. The patient was given an iv and had an electrocardiogram (ekg) performed. Additionally, patient's wife stated that during the seizure the patient bit his tongue. At the time of contact, the patient could not talk and had a sore throat. No additional event or patient information was provided.
 
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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 Key5710361
MDR Text Key47084191
Report Number3004753838-2016-03416
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 05/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTK-GF-BLU
Device Lot Number5206576
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 Received05/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2015
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: 06/09/2016 Patient Sequence Number: 1
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