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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problem Seizures (2063)
Event Date 09/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of seizures.
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on(b)(6) 2016, that the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event. The sensor was inserted at the abdomen on (b)(6) 2016. Patient reported she had a seizure between 5:30 and 6:30 am. At that time, the patient's cgm was reading 167mg/dl. Patient did not take a finder stick (fs) reading. Patient self-treated by taking ten (10) glucose tablets to bring her bring her blood glucose (bg) level back. At the time of contact, patient is good. No additional event or patient information is available. No product or data was provided for evaluation. The customer complaint could not be confirmed. A root cause could not be determined. It was reported that the patient did not calibrate after experiencing inaccuracy. It should be noted that the dexcom g4 platinum continuous glucose monitoring system user's guide states: if the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, wash your hands and take another blood glucose measurement. If the difference between this second blood glucose measurement and the sensor is still greater than 20% for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, recalibrate your sensor using the second blood glucose value. The sensor glucose reading will correct over the next 15 minutes. It was reported that the same bg meter was not used throughout the same sensor session. The dexcom g4 platinum continuous glucose monitoring system user's guide states: use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your meter in the middle of a sensor session. Blood glucose meter and strip accuracy vary between blood glucose meter brands.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key6031994
MDR Text Key57552309
Report Number3004753838-2016-80582
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 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2016
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
Device Lot NumberASKU
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 Received09/19/2016
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: 10/15/2016 Patient Sequence Number: 1
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