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

Device Problem Product Quality Problem (1506)

Patient Problems Inflammation (1932); Itching Sensation (1943); Reaction (2414)

Event Date 08/01/2020

Event Type  Injury  

Event Description

Reporter stated that he has been wearing the dexcom g6 sensor for over three years.Recently he started having problems with the adhesive on the sensor.He stated the entire area where the sensor is placed is inflamed, itchy and it takes about two weeks for it to heal.He further reported that the sensor supposed to last ten days but because of the itching it barely last three days.Reporter stated that he is allergic to the adhesive on the sensor.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10436897
• MDR Text Key: 204190182
• Report Number: MW5096186
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 86