BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 20623885 · Received November 6, 2024

    Report

    Report Number
    3009862700-2024-01059
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 21, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4. DATE OF THIS REPORT 21 JANUARY 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 21 JANUARY 2025 H6. MEDICAL DEVICE PROBLEM CODE (A) CORRECTED TO 2900.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE USER REPORTED NOT GETTING A STRONG SIGNAL AND WHEN MOVING ARM, THE SYSTEM TRIGGERS NO SENSOR DETECTED ALERT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED FOR THE RETURN OF BOTH SENSOR AND TRANSMITTER FOR FURTHER INVESTIGATION. THE RETURNED SENSOR SHOWED NO ISSUES WITH THE SENSOR FUNCTIONALITY. INVESTIGATION ON THE RETURNED TRANSMITTER SHOWED THAT THERE WAS A FIRMWARE ERROR WHICH RESULTED IN SUBOPTIMAL ANTENNA TUNING AND CONSEQUENTLY LED TO REDUCED POWER DELIVERED TO THE SENSOR. THIS ISSUE IS TO BE RESOLVED IN AN UPDATE TO THE NFC (NEAR FIELD COMMUNICATION) TUNING ALGORITHM IN AN UPCOMING FIRMWARE RELEASE. IN AN ASSOCIATED CASE (B)(4), IT ALSO WAS REPORTED THAT AN ULTRASOUND PERFORMED ON (B)(6) 2024, REVEALED THAT THE SENSOR WAS INSERTED AT AN ANGLE, WITH THE PROXIMAL END DEEPER THAN THE DISTAL END. THIS MOSTLY LIKELY CONTRIBUTED TO THE CONNECTION ISSUE BETWEEN SENSOR AND TRANSMITTER. B4: DATE OF THIS REPORT 03 JANUARY 2025. G3: DATE RECEIVED BY THE MANUFACTURER? 03 JANUARY 2025. D2B: DEVICE PRODUCT CODE UPDATED TO SBA. H3: DEVICE EVALUATED BY MANUFACTURER? YES. H6: TYPE OF INVESTIGATION UPDATED TO 10. H6: INVESTIGATION FINDINGS UPDATED TO 114. H6: INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    ON 07 OCTOBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED RECEIVING NO SENOR DETECTED ALERTS WHICH LED TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861176 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM SBA SENSEONICS INC. 103606-600 02E264S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female