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

Model Number 102208-005

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.During the initial troubleshooting call with the patient, it was determined that the issue was with the charging components.A new set of charging components was sent to the patient which resolved the heating issue.The faulty charging components could not be returned as patient disposed it off.The new set of charging components resolved the heating issue.However, transmitter was discharging prematurely and did not sustain the charge for the intended period.The transmitter was then requested to be returned for further evaluation.Although a return material authorization (rma) was issued, the product was never received.Thus, no further investigation of the complaint was possible.There is no remedial action/corrective action/preventive action/field safety corrective action required.

Event Description

Senseonics was made aware of an incident where patient complained that transmitter felt hot to touch after taking it out from the charging cradle.She used it anyway and it cooled down over time.When the patient placed the transmitter for charging again, it became warm again after a short time.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18278873
• MDR Text Key: 330430049
• Report Number: 3009862700-2023-00755
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 12/06/2023

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: 08/12/2022
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 125872
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1