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

Model Number G6

Device Problems Defective Component (2292); Separation Failure (2547); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  Injury  

Event Description

This is a dexcom g6.I used the applicator to inject the sensor per the procedure.The adhesive attached to my skin, the sensor was placed on my skin, but the applicator would not pull away from the sensor; the entire thing was stuck together.I had to remove the adhesive and the sensor in order to pull the applicator away.The sensor, adhesive, and applicator were all wasted.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12160966
• MDR Text Key: 261587016
• Report Number: MW5102502
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2021
• Device Model Number: G6
• Device Lot Number: 7280412
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 75