MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hypoglycemia event due to alleged sensor inaccuracies on (b)(6) 2021 at around 9:35 am.The reported blood glucose (bg) value was 60 mg/dl and sensor glucose (sg) value was 102 mg/dl.User did not receive low glucose alerts because the sg value never crossed the set low alert threshold of 60 mg/dl.User wasn't symptomatic, didn't seek medical treatment and did not have to self treat.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was performed on the user's data available in data management system (dms).Based on the investigation analysis, the predictive hypo alert was asserted 6 minutes after the calibration entry at 9:35 am cet on (b)(6) 2022.At the time of the event, the system did display temporary differences between the sensor reading and fingerstick measurement.The temporary difference was mitigated by the assertion of the predictive hypo alert following the calibration entry.The system demonstrated the inherent lag in the sensing technology of the sensor and that the sensor glucose eventually caught up to the calibration (capillary) entry within 3-4 sensor readings.Following the event, the system displayed good agreement between the sensor readings and fingerstick measurements.No further investigation was found necessary for this complaint.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009364
• MDR Text Key: 338979524
• Report Number: 3009862700-2024-00320
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 03/31/2024

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: 03/02/2022
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 123340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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): Other