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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM G4 PLATINUM SENSOR

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DEXCOM G4 PLATINUM SENSOR Back to Search Results
Model Number STS-GL-041
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Rash (2033)
Event Date 12/15/2015
Event Type  Injury  
Event Description
My daughter has type 1 diabetes and uses a dexcom g4 continuous glucose sensor. The adhesive for these devices causes a serious rash at the site of the sensor and pump. We change the pump pods every 3 days and the sensors every 7. We have to use barriers underneath both in order to curb the rash, otherwise the itching, redness and bleeding become too much to bear.
 
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Brand NameG4 PLATINUM SENSOR
Type of DeviceG4 PLATINUM SENSOR
Manufacturer (Section D)
DEXCOM
MDR Report Key5347260
MDR Text Key35243444
Report NumberMW5058893
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2016
Device Model NumberSTS-GL-041
Device Lot Number5201015
Other Device ID Number(01)30386270000010
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/03/2016 Patient Sequence Number: 1
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