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

Model Number 102208-500

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On may 07th 2021, senseonics was made aware of an adverse event where user experienced hypoglycemia when the user was not getting glucose values on the eversense app as the transmitter and the sensor were getting disconnected.User was guided through eversense app to gather the readings obtained during the event, but user mentioned there was a gap there, that everything was white from 05:00 pm est to 07:00 pm est, approximately.After troubleshooting, user confirmed that none of the issues user was having before (no sensor detected, no values being displayed) haven't occurred again and was all set.

Manufacturer Narrative

Based on the analysis, during the event, the system did not assert any hypo alerts due to loss of communication between the sensor and the transmitter.After the event, the customer support team assisted the user with troubleshooting the issue and after the troubleshooting, the user confirmed seeing continuous glucose readings.The issue was temporary, and it was resolved through troubleshooting.

• 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: 11944633
• MDR Text Key: 254509221
• Report Number: 3009862700-2021-00079
• 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: 05/07/2021

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: 01/13/2021
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 117537
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/06/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR