MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR

Model Number 102208-500

Device Problem Inaccurate Information (4051)

Patient Problem Hyperglycemia (1905)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event and was admitted to the hospital for diabetic ketoacidosis with a blood glucose value of 500 and a sensor glucose value of 160.The user was discharged from the hospital two days later.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONCIS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: angela bandy ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3014072878
• MDR Report Key: 8760808
• MDR Text Key: 150024099
• Report Number: 3009862700-2019-00029
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention