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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 Imprecision (1307); Use of Device Problem (1670)
Patient Problems Fatigue (1849); Hypoglycemia (1912)
Event Date 08/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced continuous glucose monitor (cgm) inaccuracies and an adverse event. The sensor was inserted in to the abdomen on (b)(6) 2017. The patient was asleep and her boyfriend noticed she was low and woke her up. The cgm was reading 75 mg/dl and the patient's boyfriend tested the patient's blood glucose (bg) and it was 34 mg/dl. The patient's boyfriend gave the patient glucose gel and then the patient took a glucose tablet. The patient stated that after being treated, she was exhausted and went back to sleep. It was indicated that the patient did not take a finger stick after the treatment. At the time of contact, the patient was doing good. No additional patient or event information is available. Data was provided for evaluation. The reported event could not be confirmed via log review due to calibrations not available for analysis. A root cause could not be determined. The was reported that the patient did not calibrate after the inaccuracy or enter finger stick values promptly. Dexcom labeling indicates: 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. Furthermore, the guide states: to calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value.
 
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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 Key6849345
MDR Text Key85156391
Report Number3004753838-2017-76168
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 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/12/2018
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5224765
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2017
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: 09/07/2017 Patient Sequence Number: 1
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