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

Model Number 102812-67A

Device Problem Device Sensing Problem (2917)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The customer complaint could not be confirmed as sensor communicated throughout the in-vitro qc test.

Event Description

On (b)(6) 2021,senseonics was made aware of an incident where user experienced no sensor detected alert leading to early sensor removal.

Manufacturer Narrative

H3: device evaluated by manufacturer, corrected to yes.

• 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
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 13055207
• MDR Text Key: 285347772
• Report Number: 3009862700-2021-00172
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022523
• UDI-Public: 00817491022523
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2022
• Device Model Number: 102812-67A
• Device Catalogue Number: FG-4202-00-301
• Device Lot Number: WP08306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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 Age: 45 YR
• Patient Sex: Female