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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Event Date 08/03/2021
Event Type  Injury  
Event Description
Severe rash; i use the dexcom g6 as my cgm. While i enjoy the accuracy of the product, everywhere on my body that i put the sensor flares up with an allergic reaction. It becomes so itchy and unbearable, that i rarely can endure the sensor through its ten day life-span. I have tried using various medical tapes, hydrocolloid adhesives, and anti-histamine sprays to get rid of these symptoms. However, nothing i have tried nor any tricks suggested online have helped with this issue. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12280856
MDR Text Key265426926
Report NumberMW5103024
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
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