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 06/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On september 21st 2022,senseonics was made aware of an adverse event where user was almost fainted due to hypoglycemia and had to seek medical assistance by calling the school's nurse and was provided insulin tablets as medical treatment.User confirmed that she's now doing fine.

Manufacturer Narrative

The investigation did not confirm the customer complaint.A review of events shows that glucose was rapidly falling and system correctly asserted low glucose alerts from the beginning to the end of the hypoglycemic period reported by the customer.Investigation also revealed the low glucose alert threshold was set to 65 mg/dl instead of 70 mg/dl mentioned in case notes and as a result the system did not trigger low glucose alert at 1:52 pm ct when sg value was 68 mg/dl.User almost fainted, had to seek medical assistance by calling the school's nurse.User was treated with insulin tablets.User felt fine afterwards.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 19jan2022.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 15645161
• MDR Text Key: 302165406
• Report Number: 3009862700-2022-00154
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 28877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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: 65 YR
• Patient Sex: Female