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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 Irritation (1941); Pain (1994); Caustic/Chemical Burns (2549)
Event Date 03/15/2020
Event Type  Injury  
Event Description
We use the dexcom g6 continuous glucose monitor. In (b)(6) my son got the sensors in their new packaging. No big deal. The first sensor left mild irritation but came off early in his sleep. The second sensor he ripped off early because the irritation was more severe. The third sensor drove him crazy and hurt really bad but he managed to keep it on the full 10 days. When i took it off he had a severe chemical burn from the adhesive. While one dexcom, rep said they hadn't changed the adhesive formula, another said they had. (b)(6) i finally got them in the new packaging and i managed a whole 3 days before i took it off, it was painful. I have reported this to dexcom but can't get a clear response. We have been using this product for approximately a year and (b)(6) 2020 was the first time we had any issues. 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 Key10167505
MDR Text Key195940543
Report NumberMW5095055
Device Sequence Number3
Product Code MDS
Combination Product (y/n)N
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 06/15/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/09/2021
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

Patient Treatment Data
Date Received: 06/17/2020 Patient Sequence Number: 1
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