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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G6 CONTINUOUS GLUCOSE MONITOR; SENSOR GLUCOSE, MONITOR
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DEXCOM DEXCOM G6 CONTINUOUS GLUCOSE MONITOR; SENSOR GLUCOSE, MONITOR Back to Search Results
Model Number G6
Device Problems Incorrect Measurement (1383); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  Injury  
Event Description
To whom it may concern, i am a type 1 diabetic who uses the dexcom g6 continuous glucose monitor (g6).My experience with the g6 has been disappointing and i'm surprised this was approved.The problems i've encountered are scattered about but occur often.I've had blood sugar measurements from the g6 that can be nearly a 100% difference than what my traditional, finger stick glucose monitor measures.The g6 routinely goes through 15 - 60 min blackout periods with no blood sugar measurements.Lastly, i've had the transmitter device - an essential component for the g6 to work - fail 50% of the time.I'm disappointed with this medical device and shocked that the fda approved it when it's worked so poorly.I'm not an outlier either.Please do a simple (b)(6) on dexcom g6 problems and you'll find a plethora of stories on how the g6 hasn't worked.Please contact me as i'd like to discuss this further.
 
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Brand Name
DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of Device
SENSOR GLUCOSE, MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key7872533
MDR Text Key120320636
Report NumberMW5079771
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 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG6
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
Patient Age29 YR
Patient Weight86
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