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

Model Number 102208-500

Device Problem Intermittent Communication Failure (4038)

Patient Problem Hypoglycemia (1912)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results in a supplemental report.

Event Description

On november 26th, 2019 senseonics was made aware of an instance where a user had a hypoglycemia event.

Manufacturer Narrative

Based on the investigation, the system did assert the low glucose alerts around 5:40 pm est when the user set low alert threshold was crossed.The reason why the assertion of the hypo alert was delayed is because incorrect calibrations were performed prior to the event which led to sensor inaccuracies.From further analysis of the dms data, it is observed that the low alert threshold was changed from 70 mg/dl to 80mg/dl, so the system can alert the user earlier.Per the investigation, the system functioned as designed.H6 result code updated to 213.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: 9694153
• MDR Text Key: 178586426
• Report Number: 3009862700-2020-00095
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR