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

Model Number 102208-705

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 05/18/2020

Event Type  Injury  

Event Description

On may 18, 2020, senseonics was made aware of an instance where the patient experienced hypoglycemia.He reported that sensor showed 95 mg/dl whereas blood glucose meter showed 37 mg/dl.Patient solved the problem himself by eating some sugar.In the last days he had some hypoglycemic episodes and the values of eversense were very different from those of the blood glucose meter.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.He exact date and time of the event is unknown.Based on the investigation of the data available on data management system (dms), it was observed there was temporary malfunction of the system between (b)(6) 2020.During this time the system did show some discrepancies between the sensor and fingerstick measurements.On (b)(6) 2020, the system started to stabilize.It is possible that the temporary disturbance in the sensor may have been caused by bruising at the insertion site.The user continued to use the system after the reported hypo event.After the system stabilized, there was no other cases reported.

• 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: 18965282
• MDR Text Key: 338431647
• Report Number: 3009862700-2024-00134
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2020
• Device Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 115024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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