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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Catalog Number 08627-0053-03
Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Hypoglycemia (1912); Rash (2033); Fluid Discharge (2686); Blister (4537); Contact Dermatitis (4546)
Event Date 05/05/2022
Event Type  Injury  
Event Description
Both of my sons are type 1 diabetic. They are 11 and 12 years old. They both had been trying to use the dexcom g6 continuous glucose monitor. They both have contact dermatitis from the dexcom adhesive. My 12-year-old has a significantly worse reaction to the adhesive than my 11-year-old. His reaction is weeping blisters and red rash that become so wet that the whole device falls off within days of insertion. The rash remains on his arm for almost two weeks after removing the sensor. It is absolutely the adhesive, as we have tested the device by removing their adhesive and utilizing another medical tape (hypafix), as many others do, and it has completely solved his allergic reactions. This adhesive causes scarring and infections on many people, dexcom needs to be held accountable for this. I have spoken to them, but they simply direct you to your, or your child's, endocrinologist. Of note, this device also is inaccurate at least 20% of the time, but once you have a prescription for it, your insurance no longer covers the number of test strips you need to ensure that your children are safe. We almost missed a bout of hypoglycemia due to a faulty sensor, thankfully, i chose to check with two other glucose meters. As this item is often used to calculate insulin doses, it is exceedingly dangerous for it to be wrong so often. Fda safety report id (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key14855717
MDR Text Key295112737
Report NumberMW5110597
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000866
UDI-Public(01)00386270000866
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/27/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue Number08627-0053-03
Device Lot Number7307955
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 06/28/2022 Patient Sequence Number: 1
Treatment
HUMALOG; HYPAFIX MEDICAL TAPE; LANTUS
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