MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Unspecified Infection (1930)

Event Date 05/09/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an instance wherein a patient using the eversense cgm system visited his healthcare professional due to a stomach viral infection.During the visit with his doctor, the patient's eversense sensor was indicating a drop in sensor glucose readings from 140mg/dl to 107 mg/dl between 12:00pm and 12:30pm.The patient's doctor then administered glucose to the patient.The patient has not reported if his doctor administered the glucose based on the patient's eversense sensor reading or based on a blood glucose test reading.After leaving the doctor, the patient became ill around 1:00pm and 2:00pm and was taken to the hospital by his caregiver where his blood glucose was at 1070 mg/dl.The patient has not reported if the eversense cgm system provided any alerts during his doctor's visit or prior to his visit at the hospital.The patient is no longer at the hospital and has recovered.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Its not known whether the cgm system provided any alerts during his doctor's visit or prior to his visit at the hospital.Patient has recovered.No further follow up from the patient was received to make a decision.No remedial action/corrective action/preventive action / field safety corrective action is required.No further follow up from the patient was received to make a decision.Based on the available information, patient has recovered after visiting the hospital.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 18400674
• MDR Text Key: 331421873
• Report Number: 3009862700-2023-00378
• 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: 12/27/2023

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: 08/22/2019
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-XX-XXX
• Device Lot Number: 109181
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2018
• 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
• Patient Outcome(s): Hospitalization