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

Model Number 102208-500

Device Problem Imprecision (1307)

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

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On october 03rd 2020, senseonics was made aware of an adverse event where user mentioned that sensor glucose was having inaccuracies and entered an episode of hyperglycemia which resulted in hospital visit.User also had high level of ketones and admitted in hospital.User was treated with saline and discharged 4 hours later until user becomes stable.

Manufacturer Narrative

The complaint was investigated.Investigation showed that the customer was incorrectly calibrating the system and likely using sg values for bg calibration.This is not the intended use of the device.Investigation did not find any malfunction with the overall system performance.H6.Investigation findings updated to 114 h6.Investigation conclusions updated to 61.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 10775946
• MDR Text Key: 214322268
• Report Number: 3009862700-2020-00543
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• 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: 10/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 116509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/03/2020
• Supplement Dates FDA Received: 11/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR