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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 Imprecision (1307)
Patient Problems Seizures (2063); Convulsion, Tonic (2223)
Event Date 07/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event. The sensor was inserted into the upper buttocks on (b)(6) 2018. The patient's mother stated at about 4:30am on (b)(6) 2018, she heard a loud scream down the hallway and when she went to the patient's room, the patient was having a seizure. She was convulsing with her eyes rolled back and was foaming at the mouth. She indicated that the convulsing lasted about 3 minutes and the emergency medical technician's (emts) were called. The patient's mother stated she took a finger stick reading and the bg meter was 69mg/dl; however, she did not state what the dexcom cgm was reading. When the emt's arrived, they also checked the patient's bg and the meter was reading 58mg/dl. They administered the patient with dextrose and transported the patient to the hospital where they had a computer tomography (ct) scan, electroencephalography (eeg) and magnetic resonance imaging (mri) performed. Additionally, the patient's mother stated additional inaccurate values where the cgm was reading 130mg/dl and the bg meter was reading 33mg/dl. At the time of contact, the patient's mother stated the patient was doing good and would be released from the hospital on (b)(6) 2018. No additional patient or event information is available. Data was provided for investigation. Confirmation of the problem was confirmed via data. The probable 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 dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7734632
MDR Text Key115535464
Report Number3004753838-2018-084611
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 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/31/2018 Patient Sequence Number: 1
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