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

Model Number 102096-67A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The sensor was replaced and returned for analysis.The malfunction was confirmed.

Event Description

On (b)(6) 2018, senseonics was made aware of a situation where user experienced constant disconnections between transmitter and sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 9944235
• MDR Text Key: 187118189
• Report Number: 3009862700-2020-00228
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/08/2018
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP04043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2018
• 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 Age: 71 YR