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

Model Number 102208-610

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2022, senseonics was made aware of an adverse event where user experienced hyperglycemia due to inaccuracies in sensor readings and system did not alert the user.

Manufacturer Narrative

The customer's complaint of event on 13th october 2022 was confirmed via a review of the in-vivo data synced by the user on the data management system (dms).The investigation did not find any malfunction with the sensor.Instead, the dms review revealed that the customer was not properly calibrating the system, which prevented the system from adjusting correctly for better accuracy.As per the escalation response in the associated sensor inaccuracies case (complaintrec-(b)(4) the user was frequently using sg values to calibrate the system, instead of using true fingerstick bg measurements; which disrupted the calibrations and eventually led to significant deviations.User was advised to enter anything other than a true bg meter value for calibration.User wasn't symptomatic and did not have to take any actions to resolve the issue.User's hcp is aware of the event.The hcp said no resolution was required as the user's bg values were on a down trend.Per dms, user is currently using the system with up to date information.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 19.

• 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: 15785944
• MDR Text Key: 303563814
• Report Number: 3009862700-2022-00171
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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: 61 YR
• Patient Sex: Female