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

Model Number 102096-67A

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 05/20/2021

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 24th 2021, senseonics was made aware of an adverse event where the sensor broke into pieces during removal procedure.All the fragments of the sensor couldn't be retrieved.

Manufacturer Narrative

The rma was authorized but not received.Also, the customer complaint however was not confirmed, as there were no pictures provided.User had another appointment for removal of remaining fragment, but the doctor was not able to locate the fragment even after making an incision.As a result, no confirmation or investigation of this complaint is possible.User was not experiencing any pain or infection after the removal attempt.No further resolution is possible at this time.H3.Device evaluated by manufacturer? no, not returned to manufacturer.H6.Type of investigation updated to 4114.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4311.

• 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: 12038138
• MDR Text Key: 257460270
• Report Number: 3009862700-2021-00084
• 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: 05/24/2021

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: 12/04/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR