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

Device Problems Device Ingredient or Reagent Problem (2910); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 04/15/2021

Event Type  Injury  

Event Description

Red, itching, long-lasting rash due to dexcom g6 adhesive change.Fda safety report id # (b)(4).

• Brand Name: G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11731498
• MDR Text Key: 247705453
• Report Number: MW5100989
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR