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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)
Event Date 03/01/2021
Event Type  Injury  
Event Description
My last 3 dexcom g6 sensors have caused a severe rash, itching and potential scarring from the adhesive. This has never happened in 10 yrs of using the product, but now it is the last 3 sensors in a row, with unbearable skin reaction on my abdomen in 3 different spots. I was informed that they changed their adhesive recently. I called my doctor and have needed hydrocortisone and aquaphor to attempt to heal the skin. It has caused sleeplessness from itching/stinging and potential permanent skin damage, which means a loss of healthy skin area to place sensors and pump sites, which is a serious medical concern for someone with type 1 diabetes. I have now purchased expensive prep treatment and post treatment, because this technology is too helpful to my diabetes to not use. I am afraid to live life or sleep without an accurate continuous glucose monitor. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11421923
MDR Text Key238402245
Report NumberMW5099808
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/03/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received03/04/2021
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: 03/04/2021 Patient Sequence Number: 1
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