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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On january 10, 2023, senseonics was made aware of an adverse event where user experienced false hypoglycemia alerts due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation, the reported sensor inaccuracy at the time of the event could not be confirmed as there was no fingerstick measurement performed by the user at the time.However, it was observed that there was transient noise in the optical channel around the time of the event, likely impacted by the condition of the hydrogel, though unclear, at the time 'in-vivo'.After the reported event, there were four repeated suspicious calibration entries which led to a sensor suspend phase, during which the system recalibrated its glucose calculation algorithm while the sensor readings were blinded to the user for 6 hours.After the sensor suspend phase, the system re-started the initialization phase and recovered from the transient noise in the optical channel.The system started displaying better agreement between the sensor readings and fingerstick measurements, and began to perform within expectations.Per case information, user wasn't feeling symptoms, but self-treated by eating something and drinking milk.Per dms, user is currently using the system with up-to-date information, and the current system performance is within expectations.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 16428714
• MDR Text Key: 310079453
• Report Number: 3009862700-2023-00052
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male