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 02/02/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, senseonics was made aware of an incident where the user passed out and went to the emergency room due to low glucose results not detected by transmitter.

Manufacturer Narrative

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

Manufacturer Narrative

A review of the sensor's data showed that the system was being inaccurate around the date and time of the reported missed pm7 (hypo) event.The investigation revealed that the cause of the inaccuracy was the inappropriate calibration done by the customer a day before when he entered the sg values in the system for calibration, instead of bg values from his meter.No malfunction was found after the review of the sensor's key performance metrics.Per case notes, the user was taken to emergency room (er) where she was provided with an iv.User felt fine afterwards.User has stopped using the system based on dms and customer care was not able to reach the user since she has been unresponsive.No further resolution was possible.D9.Device available for evaluation? no.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: 13690641
• MDR Text Key: 286737175
• Report Number: 3009862700-2022-00039
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022516
• UDI-Public: 00817491022516
• 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: 02/05/2022

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: 03/11/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3302-01-001
• Device Lot Number: 123070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 02/05/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female