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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)
Event Date 12/20/2020
Event Type  Injury  
Event Description
Chemical burn and blisters; this involves a dexcom g6 continuous glucose monitoring system.The problem is the adhesive on the sensor.I have tried numerous attempts at mediating the adhesive reaction including: liquid barrier films, flonase spray on skin, tegaderm film, leaving the tabs on the adhesive and attaching with large tegaderm film overall.I used the dexcom g4 with no problem but apparently the adhesive has been reformulated.There is an entire (b)(6) group of people having reactions to the adhesive on the g6.There is really no test for this as it is a skin reaction 2 an adhesive.Fda safety report id# (b)(4).
 
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Brand Name
DEXCOM G6 CGM
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11421891
MDR Text Key238392083
Report NumberMW5099807
Device Sequence Number2
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 03/02/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/04/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight68
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