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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 02/22/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, senseonics was made aware of an incident where user experienced hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the investigation analysis, there was temporary mismatch between the sensor readings and the fingerstick measurement.The hypo alert was asserted incorrectly at the time of the reported event due to the temporary difference between the sensor reading and the fingerstick measurement.After the event, the system displayed better agreement between the sensor readings and fingerstick measurements.As per notes, user wasn't symptomatic and didn't seek medical treatment for her hypoglycemic event.User was advised to let the hcp know of these events.H3.Device evaluated by manufacturer? yes.Not returned to manufacturer.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 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: 13795050
• MDR Text Key: 287328438
• Report Number: 3009862700-2022-00042
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 02/22/2022

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: 04/27/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 123772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 Age: 53 YR
• Patient Sex: Female