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

Model Number 102096-67A

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, senseonics was made aware of an incident where user called in to report constant "new sensor detected " alerts and was not able to calibrate or get a stable signal which leads to early sensor removal.

Manufacturer Narrative

Per the case notes it was captured that there were 2 sensors inserted at the same location - they were inserted in very close proximity of each other.Per the initial escalation analysis, it was shared that since the transmitter was detecting two sensors because both sensors were inserted in close proximity of each other and, as dms was showing (b)(6) 2020 as the insertion date for both sensors, this would prevent the user from using the system properly.Based on the findings, it was decided to remove the sensor upon user consent and an rma was authorized.The rma was not received and therefore, no further investigation could be performed at this time.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 10892180
• MDR Text Key: 217965058
• Report Number: 3009862700-2020-00577
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• 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: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 10/24/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR