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

Lot Number 5283097

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146); Sleep Dysfunction (2517); Caustic/Chemical Burns (2549); Superficial (First Degree) Burn (2685); Skin Disorders (4543)

Event Date 03/10/2021

Event Type  Injury  

Event Description

After using dexcom g6 cgm sensor patches for several months i got a terrible chemical burn from a new package of sensors.I reported the issue to dexcom, they made note of it and sent replacement.Several replacements and subsequent packages obtained through my pharmacy also caused burns, some dissolving the upper layers of skin so badly that it took weeks to heal.All incidents were reported to dexcom and photographed by myself for future reference.These issues were also reported to my diabetic management team.Dexcom has repeatedly assured me that no changes were made to their adhesive, but no other brand of medical patches, films, or bandages has caused any skin reaction, including over-patches and tegaderm films used at the sensor sites (only the skin directly in contact with the g6 patches was damaged).The damaged skin is red, weeping, becomes scaled and peeling, and itches and burns badly enough to wake me from deep sleep.All reactions have occurred within two or three days of sensor insertion.Often the damaged skin beneath the patch causes the sensor patch to fall off due to the skin layer it's adhered to dissolving/failing, usually many days before the patch is due to be changed.In response to these issues, dexcom has sent replacements (thus far, equally faulty, save one) and referred me to their faq webpage, which cannot solve this issue.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11929810
• MDR Text Key: 254320659
• Report Number: MW5101678
• Device Sequence Number: 1
• 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: 05/31/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Lot Number: 5283097
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 93