MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 102208-500

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

User was at "(b)(6)" for snowboarding with friends.He returned home early from his trip because of high glucose and his mother took him to the hospital (b)(6) 2020 around noon with a bg in the 400s.User was released later that day, (b)(6) 2020, as glucose started to come down.He was prescribed anti-nausea medication at discharge.He was given fluids to feel better because of his ketosis.

Manufacturer Narrative

From the information available, the customer was not wearing the transmitter or using the system on the day of the event (and even preceding days leading to the event).Per design, the customer will not get any alerts whatsoever if they are not using the system.The customer was subsequently helped by customer care to get the system up and running.Dms analysis shows that customer started using system on (b)(6) and has been using system since then.H6 result code updated to 3221.H6 conclusion code updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• MDR Report Key: 9700276
• MDR Text Key: 178785579
• Report Number: 3009862700-2020-00099
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 817491021441
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2019
• Device Model Number: 102208-500
• Device Lot Number: 107537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR