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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 12/09/2022

Event Type  Injury  

Event Description

I'm using the dexcom g6 sensor.After application, within a day, it begins to itch.Of course i can't actually scratch the itch as it's under an adhesive patch.For the next 10 days until the sensor expires, the itch will come and go.Upon removal of the sensor, i'm left with an oval mark where the skin was irritated by the sensor patch adhesive.In mild cases, it's left a rash.In the worst case, the area was red, inflamed and was bleeding.

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 15979831
• MDR Text Key: 305557738
• Report Number: MW5113775
• Device Sequence Number: 1
• 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
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BABY ASPIRIN.; HUMALOG, METFORMIN, AMLODIPINE, LOSARTAN, ROSUVASTATIN.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian