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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 Problem Seizures (2063)
Event Date 09/17/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of seizures.
 
Event Description
Dexcom was made aware on 09/29/2016 that on (b)(6) 2016, the patient experienced a seizure. Patient's mother reported that the sensor failed and was removed without the mother's knowledge. Patient then experienced a seizure. Patient's mother took a finger stick (fs) and the patient's blood glucose (bg) was 247 mg/dl. Patient's mother administered glucagon and paramedics were called. The patient was taken to the hospital. Patient's mother reported that the patient was treated with an iv with sugar water and stayed at the hospital until levels stabilized and a new sensor was inserted. Patient left hospital the next day, (b)(6) 2016. There was no alleged device malfunction. At the time of contact, patient is healthy. No product or data was provided for evaluation. The customer complaint 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 Key6055866
MDR Text Key58353381
Report Number3004753838-2016-80627
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 09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
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 Received09/29/2016
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: 10/25/2016 Patient Sequence Number: 1
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