BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21307297 · Received February 4, 2025

    Report

    Report Number
    3009862700-2025-00174
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    November 13, 2024
    Report Date
    February 4, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW. THE USER REPORTED INACCURATE READINGS. THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER REVIEW. IT WAS SUGGESTED THAT THE USER PERFORM A SENSOR RELINK. CUSTOMER CARE CONTACTED THE USER TO CONTINUE THE PROCESS AND THE USER REPORTED THAT THEY HAD ALREADY RE-LINKED THEIR SENSOR AND THE VALUES WERE ACCURATE. NO FURTHER ASSISTANCE WAS REQUIRED.

    Description of Event or Problem · 0

    SENSONICS WAS MADE AWARE OF AN INCIDENT IN WHICH A USER REPORTED SENSOR INACCURACIES WHILE USING THE SYSTEM.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER PROVIDED THE FOLLOWING EXAMPLE: (B)(6) 2024: BG: 199 MG/DL / SG: 289 MG/DL. BG: 207 MG/DL / SG: 292 MG/DL. BG: 162 MG/DL / SG: 219 MG/DL. BG: 152 MG/DL / SG: 154 MG/DL. AFTER COMPLETING TROUBLESHOOTING, IT WAS FOUND THAT THE CASE NEEDS TO BE ESCALATED AND A DIAGNOSTIC UPLOAD IS REQUIRED.USER WAS INFORMED THAT THE CASE WILL BE ESCALATED LOOKING FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64282 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 103606-600 01E274S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male