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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
Lot Number 7278683
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Burning Sensation (2146); Skin Tears (2516); Contact Dermatitis (4546)
Event Type  Injury  
Event Description
In use of the dexcom g6, the past 2 sensors i have used seriously damaged my skin. The adhesive has given me dermatitis, as diagnosed from the dermatologist i visited/had to receive a prescription cream for it. In the past, use of the dexcom would only leave a small bump from where the needle/wire was inserted into my arm. Other type 1 diabetics i know report the same issue. Starting this summer. The adhesive leaves my skin painfully raw, itchy, red, stinging, and hard to the touch, with multiple scabs (approx 20-30 small ones per dexcom use) in the shape of/within the oval shape of the dexcom (about 2 inches). It has not healed in the 2 weeks since i removed the first sensor, nor in the 3 days since i removed the second sensor. I contacted dexcom customer service and was simply told that their adhesive was medically tested/met standards, and i asked that my complaint/need for a doctor's visit/prescription be recorded. I'm left with no choice but to continue use of the dexcom at risk of the skin on my arms lest my blood sugar control worsen. 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 Key11261129
MDR Text Key230057161
Report NumberMW5099117
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 01/27/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/04/2021
Device Lot Number7278683
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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