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

Lot Number 7279759

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Itching Sensation (1943); Scarring (2061); Reaction (2414)

Event Date 10/28/2020

Event Type  Injury  

Event Description

I've been using dexcom sensors for almost 6 years, but only recently did i start having a severe reaction to the adhesive (around end of october).Due to lack of transparency/communication i thought i was doing something wrong or had developed an allergy.I discussed this with my endocrinologist in december after trying to use the sensors three times, all resulting in red, itchy, bumpy, puffy skin in the exact oval of the sensor.They said that allergies typically develop soon after starting the product initially so she didn't think an allergy was causing the reaction, just a bad batch of sensors.I spoke with dexcom a few times and found out after several calls and complaints that in (b)(6) of 2019 they changed the adhesive without notifying consumers.They let me know that this new sensor adhesive didn't reach many consumers until recently for warehouse/storage reasons.Many of their recommendations indicated that they believed the reaction to be allergy related (although i don't have any other known skin allergies).And when asked to view a list of ingredients (i'm concerned about needing to know what i could be allergic to), they weren't able to disclose that.Months later, the spots where i had applied sensors (the three old sites are in between my lower abdomen and back areas on both my right and left sides) still itch at times.So i have phantom itchiness and dark oval scarring from the sensors.The skin is sort of dry in those areas and even though i've been applying cortisone cream, it's still irritated at times, especially after a warm shower.I believe on all three sites where i had direct skin contact with the sensors, i couldn't wear them the full 10 days.After two days the itchiness began.The first sensor in october also didn't irritate my skin quite as bad as the two after.Fda safety report id # (b)(4).

• Brand Name: G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11285583
• MDR Text Key: 230730549
• Report Number: MW5099242
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 7279759
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 66