MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 SENSOR 3'S; SENSOR, GLUCOSE, INVASIVE

Lot Number 7284759

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Event Description

Sensor that should last 10 days failed upon application and had to be replaced.

• Brand Name: DEXCOM G6 SENSOR 3'S
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 11581432
• MDR Text Key: 242990021
• Report Number: MW5100329
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 08627005303
• UDI-Public: 08627005303
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 7284759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR