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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

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DEXCOM, INC. DEXCOM G6 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG Back to Search Results
Model Number G6
Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)
Patient Problems Hemorrhage/Bleeding (1888); Skin Discoloration (2074)
Event Date 08/25/2020
Event Type  Injury  
Event Description
I have had several calls into dexcom that their sensors that are marketed to last 10 are only last on average 7-8 days.I have had several sensors replaced over the years.In addition, the device that launches the sensor onto the body to release the sensor did not release when the device was pushed, and had to pull until the unit from my body that caused it to bleed and area around was all black and blue.I have photos for proof of this happening.Apply new sensors every 10 days; applied to the skin.Reason for use: diabetic and helps in keeping track of blood sugar read outs.I have been using the dexcom g6 for the last few years replacing sensors every 10 days.
 
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Brand Name
DEXCOM G6 SENSOR
Type of Device
INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10553235
MDR Text Key207721233
Report NumberMW5096739
Device Sequence Number2
Product Code QDK
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG6
Device Lot Number7273627
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/17/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient Weight64
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