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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 Stroke/CVA (1770); Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated outcomes.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced an adverse event. The patient's mother reported that the patient required medical attention while wearing the dexcom continuous glucose monitoring (cgm) system. The patient's roommate found the patient unresponsive after a day of not moving and/or sleeping. The patient's roommate called the paramedics, who administered glucagon and transported the patient to the emergency room (er). Upon arrival, the patient was still unconscious and started seizing. The patient was then moved to the intensive care unit (icu) and testing concluded that the patient's unresponsive state was due to 3 mini strokes caused by a lack of sugar to the brain. On (b)(6) 2016, the patient started showing signs of responsiveness and was transferred over to outpatient rehabilitation on (b)(6) 2016. The patient was in outpatient rehabilitation for 10 days, where she showed improvement on her occupational and physical therapy. There was no alleged device malfunction. At the time of contact, the patient was stable. Additional event or patient information was not provided. No product or data was provided for evaluation. The reported 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 Key6058039
MDR Text Key58413465
Report Number3004753838-2016-80620
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 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2016
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 Received10/03/2016
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: 10/26/2016 Patient Sequence Number: 1
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