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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
Model Number G6 SENSORS
Device Problem Product Quality Problem (1506)
Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Scarring (2061); Swelling (2091); Reaction (2414)
Event Date 11/10/2020
Event Type  Injury  
Event Description
Using a new dexcom g6 sensor, my skin became inflamed, itchy, and a red welt develops around these adhesives on the sensors. Using previous versions (g5, 4) does not produce this; insulin-delivery ports (medtronic minimed) are used all the time, and they do not produce the same welt/scarring/inflammation. I alternate the sensor locations, and each time the g6 welt remains for 2-3 weeks. I am now getting covered in the scars/welt. I was using previous versions of this attached medical device (g5, and g4) which are no longer available. The new g6 model is different in that it is attached for 10 days, and not 7. The adhesive has changed to make it last/stay attached over that longer period. Only the new g6 model is causing this reaction on me, and there are numerous other affected people with the same reaction happening to them with this new g6 as well. 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 Key10894208
MDR Text Key218204864
Report NumberMW5098035
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6 SENSORS
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: 11/23/2020 Patient Sequence Number: 1
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