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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Local Reaction (2035); Blister (4537); Swelling/ Edema (4577)

Event Date 12/08/2020

Event Type  Injury  

Event Description

I developed allergic reactions to the adhesive on the band aid of my dexcom g6 glucose monitor in (b)(6) 2020.With direct skin contact with the band aid i develop itchy, swollen, red and blister-filled skin in the area where the sensor was placed.I was told that a lot of people have this problem after the latest change in dexcom's band aid adhesive.I have had an allergy test done on my skin at my local hospital which showed signs of allergy towards my dexcom g6 band aid, but unfortunately no reaction towards any of the known allergens also tested for, except for nickel and linalool.Since dexcom will not inform me about the specific contents of their band aid, i cannot figure out exactly which chemical in it i might be allergic to.My newly developed allergy has led me to needing multiple products to separate my skin from my dexcom g6 band aid, since i can no longer stand having direct skin contact with it.Apart from that, i have multiple areas on my skin damaged from previous allergic reactions, that can not currently be used as base for application of new glucose sensors.Furthermore i have needed the use of several products containing steroid hormones applied to my skin to lower my allergic response, which my doctor at the local allergy clinic tells me i cannot continue doing because it will damage my skin even further.The incident has been reported to the (b)(4) as well as the danish medicines agency.Fda safety report id # (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11760314
• MDR Text Key: 248831636
• Report Number: MW5101115
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/29/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 57