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

Lot Number 7294029

Device Problems Separation Failure (2547); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

The dexcom g6 sensor did not release and it had to be pulled off the skin.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: 13151901
• MDR Text Key: 283305221
• Report Number: MW5106430
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Lot Number: 7294029
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TANDEM INSULIN PUMP
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White