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

Model Number 101967-750

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/02/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a serious adverse event where patient accidentally tore out stitches (after sensor insertion procedure) which resulted in bleeding.Patient went to primary care center for treatment where stitches were redone.Patient is currently feeling fine and wound has healed.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The adverse event happened as a result of patient accidentally tearing the stitches (after sensor insertion procedure) resulting in bleeding.The patient visited primary care center where stitches were redone.Patient is currently feeling fine and the wound is healed.No further investigation or actions were found necessary for this complaint.

• Brand Name: EVERSENSE SENSOR
• 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: 18484813
• MDR Text Key: 332562548
• Report Number: 3009862700-2023-00803
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

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: 09/26/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other