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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 CONTINOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypoglycemia (1912)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on 12/05/2016, that on (b)(6) 2016, an adverse event had occurred. The patient stated the she was hospitalized because of low blood sugar. The patient's son called 911 on (b)(6) 2016. The patient was taken to hospital by ambulance and treated with iv of fluids and insulin, in addition to treatment for a urinary tract infection (uti). The patient was hospitalized for a week, then released on (b)(6) 2016. The patient reports that dexcom equipment worked perfectly and the sensor and transmitter were taken off at hospital, then misplaced. No product defects or failures were alleged. At time of contact the patient was doing ok. No additional event or patient information was available.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6216739
MDR Text Key63687412
Report Number3004753838-2016-88501
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 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
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 Received12/05/2016
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

Patient Treatment Data
Date Received: 12/30/2016 Patient Sequence Number: 1
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