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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 9500-44
Device Problems Imprecision (1307); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted into the abdomen on (b)(6) 2018. Reportedly, calibrations were entered during periods of rapid rate of change. Reportedly, calibrations were entered during periods when cgm values were not present. No additional event or patient information is available. No data was provided for evaluation. The complaint confirmation of the reported inaccuracy could not be determined. A root cause could not be determined. Labeling indicates: do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dl per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy. Labeling indicates: don't calibrate. Wait 10 minutes. Move display device and transmitter within 20 feet of each other without obstruction. Wait another 10 minutes. Labeling indicates: when your display device has system errors, you may not receive any sensor glucose readings and you should not calibrate.
 
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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 Key7622991
MDR Text Key112015282
Report Number3004753838-2018-67186
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot Number5228728
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 Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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