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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 06/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event that occurred on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. The patient stated she started to have a seizure since the cgm did not register her low. It was reported that at the time of the inaccuracy, the cgm read 175mg/dl compared to the bg meter which read 45mg/dl. The patient's husband administered two glucagon injections. Following this, the patient's husband removed the sensor and applied a new one, which the patient said was within the accuracy range. At the time of contact, the patient was stable. Data was evaluated on 07/14/2016. The reported event of cgm inaccuracies was confirmed. A root cause could not be determined. Calibration was not performed after experiencing inaccuracy. The dexcom g5 mobile continuous glucose monitoring system states: if the cgm values are outside the 20/20 range, calibrate again.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5801538
MDR Text Key49735392
Report Number3004753838-2016-38792
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 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/16/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5207629
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 Received06/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2015
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: 07/17/2016 Patient Sequence Number: 1
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