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

Model Number 102208-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Sweating (2444)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

The patient was sweating while asleep and ambulance was called in by her husband but not hospitalized.The patient was treated with iv glucose and was doing much better.No further investigation is required.

Event Description

On (b)(6) 2020,senseonics was made aware of an adverse event where the patient experienced hypoglycemia event due to sensor inaccuracy.Patient husband noticed that she was sweating and limp when she was asleep and paramedics was called in but not hospitalized.

Manufacturer Narrative

In the response to fda request, based on the investigation and the case notes, it is concluded that the sensor glucose readings were inaccurate due to a faulty glucometer, confirmed by user's doctor.These bad calibrations impacted how the sensor glucose readings were calculated and as a result displayed high glucose readings instead of low glucose readings during the hypo event.However, the patient was treated with iv glucose and was doing much better.H6 conclusion code updated to 19.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• MDR Report Key: 9916084
• MDR Text Key: 186162786
• Report Number: 3009862700-2020-00398
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR