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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 07/15/2021

Event Type  Injury  

Event Description

On july 15, 2021, senseonics was made aware of an incident where patient experienced a hypoglycemia event.Patient felt very weak and was barely able to see at the time of incident.Sensor glucose (sg) was 96 mg/dl where as blood glucose (bg) was 37 mg/dl.Patient complained that she did not receive any low glucose alert on her device.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation analysis, it was observed that due to change in the optical channel measurements, the performance of the sensor was temporarily affected between the 12th and 20th of july.It was suggested that either the user give the system a few more days to recover or a sensor removal would be supported if the user does not want to continue with the sensor (b)(6) and the rma would be authorized to bring back the sensor for further root cause analysis.User expressed unwillingness to continue with eversense, and the user would not get re-inserted with another sensor.The sensor was investigated after it was received, and the issue was not confirmed during in-house testing as the problem could not be duplicated during in-house investigation.Hence, root cause cannot be determined, therefore no further investigation is possible for this sensor at this time.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18976384
• MDR Text Key: 338551612
• Report Number: 3009862700-2024-00217
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023087
• UDI-Public: 817491023087
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other