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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 UKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 03/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a hypoglycemic event on (b)(6) 2016. The patient had a severe low and had a seizure. Patient also had headaches. The patient's mother called 911 after she administered the patient a glucagon shot. The ambulance came and after examining the patient, gave her fluids and the released her. Patient's parents drove the patient back to the hospital a few hours later, as they were unable to bring her blood glucose back up. Patient was given some pain medication and fluids and was released. Patient was not wearing the continuous glucose monitor at the time of the event, as they were waiting for a new transmitter as theirs had an issue. Additional event or patient information was not 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 Key5577006
MDR Text Key42661719
Report Number3004753838-2016-02244
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 03/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUKNOWN
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 Received03/15/2016
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: 04/14/2016 Patient Sequence Number: 1
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