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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 DEXCOM G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Impaired Healing (2378)
Event Date 07/30/2020
Event Type  Injury  
Event Description
Dexcom g6 sensors have new or enhanced adhesive formulation. Sensors are required to last 10 days. Sensors will only last 4-5 days due to severe skin irritation. Area extremely inflamed and itchy. Upon removing sensor, skin is raw and weepy. Takes 3-4 weeks for skin to heal. Have heard reports of same issue occurring with many other dexcom g6 users. 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 Key10361579
MDR Text Key201762748
Report NumberMW5095857
Device Sequence Number1
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 07/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/17/2021
Device Model NumberDEXCOM G6
Device Lot Number5273487
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

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