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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Scar Tissue (2060); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)
Event Date 01/01/2021
Event Type  Injury  
Event Description
"scarring to the skin" when the sensor is removed every 10 days from the abdomen area, it leaves a tremendous irritation where the adhesive holds the sensor in place. It takes 4-6 weeks for each area to heal, so after 4-6 weeks a patients entire stomach area is filled with terrible irritation, blotches, rough skin, etc. According to various blogs for diabetics, there are over 13,000 people with this problem. Technology is good when the machine works but many times breaks down. Biggest problem is that the skin is destroyed when the sensor is removed and changed. Pictures have been taken over a 6 moth period. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12662357
MDR Text Key277684149
Report NumberMW5104732
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 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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: 10/18/2021 Patient Sequence Number: 1
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