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

Model Number 102208-705

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 11/11/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where patient experienced hyperglycemia event.Patient reported that blood glucose meter showed 300 mg/dl and eversense reported 125 mg/dl.Patient did not require medical attention and managed the situation on her own by injecting insulin.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Customer complaint cannot be confirmed.The exact date/time of the event is unclear and repeated efforts to clarify this information from the customer were not successful.Analysis two weeks before the event reported date shows that the bg value of 300mg/dl mentioned by customer was not entered into the system.Investigation two weeks before event reported date did not find evidence of any malfunction.

• 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: 18969184
• MDR Text Key: 338496174
• Report Number: 3009862700-2024-00161
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/25/2024

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: 09/09/2020
• Device Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 71987
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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): Other