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

Model Number G6

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Burns bleeding, damaged skin; got a pack of 3 sensors from dexcom for g6 cgm.Been using since (b)(6) 2019 with no problems.With these sensors at the end of their 10 day run when they were removed skin beneath the adhesive patch was raw, bleeding, oozing, red and swollen.Had to remove the last one at 6 days because it was becoming very painful.Three days later it is still tender and sore to the touch.Fda safety report id # (b)(4).

• Brand Name: DEXCOM CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10096231
• MDR Text Key: 192704666
• Report Number: MW5094718
• 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: 05/25/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 78