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

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).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 14855717
• MDR Text Key: 295112737
• Report Number: MW5110597
• Device Sequence Number: 2
• Product Code: MDS
• 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: 06/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: HUMALOG; HYPAFIX MEDICAL TAPE; LANTUS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White