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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Date 06/10/2020
Event Type  Injury  
Event Description
I have been wearing the dexcom g6 cgm since january of this year without an issue. Until i rec'd my second order of the cgm sensors. Since the end of may i have experienced itching upon placing the g6 sensor on my stomach from the adhesive. Upon removing the cgm 10 days later i have a blistering 2x3 inch rash. I checked the faqs for experiencing a bad reaction on the dexcom site and as a preventative applied an iv 3000 barrier film on my skin and then placed a new sensor on that. However i had to remove the second sensor earlier than 10 days and when i did i had another red rash 2x3 rash. I called dexcom today to report this and the customer support person was a terrible listener as i started by telling him my bad sensor adhesive experience and that i had been seen by my endocrinologist (who could not believe the blistering rash i have), have been placed on both an antibiotic and betamethasone valer 0. 1% ointm ointment cream. I told the customer service rep that i read the faqs on the dexcom site. But as is typical, he was not listening, he directed me to the faq document and to my endocrinologist. Finally i got him to understand that i was calling to report my adverse reaction to the sensor adhesive. He took the lot number from the sensor box and opened a case. I pressed him on if dexcom had changed the adhesive and he said yes there had been a slight change recently. I then pressed him if my feedback would be shared with the product team and he responded that he had opened a case but would not say who reviews the cases or how often. This is really frustrating because i had no issues until the last 2 cgm sensors. (b)(4).
 
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Brand NameSENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10179855
MDR Text Key196151602
Report NumberMW5095134
Device Sequence Number3
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/18/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/19/2020
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: 06/19/2020 Patient Sequence Number: 1
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