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

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

We currently use the dexcom g6 system and the sensors are advertised and sold as 10 day sensors.However, it is on a very rare occasion that they last that long.I have had to call almost every week to get a replacement sensor because my daughter's has failed.This product is advertised as an alternative to finger sticks so we rely on it very heavily to catch her highs and lows but it has stopped working in the middle of the night after only 3 or 4 days for 30 mins to 3 hours.It gives a "sensor error" message stating it may take up to 3 hours to correct the problem.This happens with every sensor we have used since switching to the g6.Some times they correct themselves but more times than not i have to call dexcom because it won't correct itself or it completely shuts down the sensor causing no readings at all.When this happens in the middle of the night, it puts my child's life at risk and when i speak to dexcom about it they act like it is no big deal.Like it is completely normal and fine that their product has put my child's life at risk.If the fda has approved this product with the knowledge that this problems exists then shame on you.If the fda approved this product without the knowledge of these problem then please do something about it.Dexcom charges a ridiculous amount of money for their product that fails every week.This needs to be addressed asap before someone's child, or an adult, dies because of their failed products.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9124263
• MDR Text Key: 160373851
• Report Number: MW5090051
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening