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

Model Number 102208-620

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 28 october 2022, senseonics was made aware of an adverse event where user was hospitalized due to a high glucose event on (b)(6) 2022.During hospitalization user was treated with insulin via iv, no medication was prescribed after the event.User confirmed that he's doing fine and he is almost back to normal.

Manufacturer Narrative

The investigation did not reveal any malfunction with the sensor.However, it did reveal that the customer was not properly calibrating the system, which likely would have prevented the system from adjusting correctly for better accuracy, leading to missed adverse events.User was hospitalized where he was treated with insulin via iv.No medication was prescribed.Per case notes of associated sensor inaccuracies issue (complaintre(b)(6) ), user was educated on calibration best practices and was reminded to use true finger stick blood glucose (bg) value for calibration and not to enter estimated values shown by the system.No further resolution was found necessary for this complaint.D4.Updated additional device information.H3.Device evaluated by manufacturer?: yes.H4.Device manufacturer date updated to 04mar2022.H6.Investigation findings updated to 3250.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: 15870691
• MDR Text Key: 304373595
• Report Number: 3009862700-2022-00182
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male