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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6 SENSOR (STS-OR-003)
Device Problems Difficult to Remove (1528); Activation, Positioning or SeparationProblem (2906)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Skin Inflammation/ Irritation (4545)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
I use the dexcom g6 cgm system; 4 out of 6 sensors from lot 7279782 and 1 out of 2 sensors from lot 7283346 that i have attempted to insert have failed to detach from the applicator. When the applicator fails to detach, the insertion needle remains embedded in the skin until the adhesive is removed. This has caused pain, bleeding, and skin irritation at the insertion site. The product must be removed and disposed of if it fails to deploy. The strong adhesive makes the sensor difficult to remove, prolonging the time where the applicator needle remains painfully embedded in the body. Dexcom has replaced the failed sensors, but has refused to replace or recall unopened sensors from the same batch, despite admitting that a known manufacturing defect causes the sensors to fail to deploy. Repeated sensor insertion failures have caused me physical and mental trauma, and have resulted in anxiety and reluctance to use the medically prescribed product. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12353653
MDR Text Key267856399
Report NumberMW5103382
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 08/18/2021
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6 SENSOR (STS-OR-003)
Device Lot Number7283346
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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