MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

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

Patient Problems Bone Fracture(s) (1870); Hypoglycemia (1912); Hypoglycemic Shock (4575)

Event Date 08/08/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Data management system (dms) analysis showed that the user was provided low glucose and out of range low glucose alerts continuously for about 2.5 hours before the event time on the event date.The system functioned as intended and no malfunction was observed.The user reported that his condition had been getting better.No further follow up was possible due to no response from the distributor.

Event Description

Senseonics was made aware of an incident where the patient experienced epileptic shock due to hypoglycemia.Patient had cramps split the fourth lumbar and one thoracic vertebra and broke the shoulder.Ambulance was called around 6 a.M.Sugar was not measured because of suspected meningitis.The patient was operated three times, twice on the shoulder and once on the spine.The last reading from the eversense app was 2.8 mmol / l.The patient was still in the hospital at the time when this event was made aware, and was to be transferred to a rehab in a few days.The patient reported that now he was still using the system, but pump therapy was cancelled.The patient's condition was bad but had been getting better.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18488930
• MDR Text Key: 332601050
• Report Number: 3009862700-2023-00493
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 01/10/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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