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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
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)
Event Date 07/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of hyperglycemia and its associated effects.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced an adverse event on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Patient states that when she woke up at 6:00 a. M. She had the question marks symbol displayed on her device. The patient did a finger stick and had a blood glucose (bg) value of 333mg/dl. She proceeded to take 10 units of novolog insulin and drank 2 liters of water throughout the course of the next 6 hours. Patient stated that she was very dehydrated and decided to drive herself to the emergency room (er) at approximately 12:00 p. M. And arrived at approximately 12:30 p. M. The patient was treated by an endocrinologist and was treated with an iv containing saline and zofran for vomiting. The patient was released the next day, (b)(6) 2016, around 5:00 p. M. No additional event or patient information was provided. No product or data was returned 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 Key5876940
MDR Text Key52130661
Report Number3004753838-2016-80057
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 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/11/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-041
Device Lot Number5203092
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 Received07/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/15/2016 Patient Sequence Number: 1
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