BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21367755 · Received February 12, 2025

    Report

    Report Number
    3009862700-2025-00173
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    December 21, 2024
    Report Date
    March 20, 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

    THE CUSTOMER REPORTED THAT THEIR NEW TRANSMITTER WAS PROVIDING INACCURATE GLUCOSE READINGS, WHICH WERE OFF BY 150 UNITS. THE CUSTOMER PROVIDED SEVERAL EXAMPLES OF DISCREPANCIES BETWEEN SENSOR GLUCOSE (SG) AND BLOOD GLUCOSE (BG) VALUES: ON (B)(6) 2024, 2:17 PM: SG 65, BG 211. ON (B)(6) 2024, 4:05 PM: SG 86, BG 258. ON (B)(6) 2024, 4:55 PM: SG 86, BG 261. THE ISSUE WAS ESCALATED TO THE NEXT LEVEL OF SUPPORT, AND THE CUSTOMER WAS ADVISED TO CONTINUE USING THE SYSTEM AND CALIBRATING AS REQUESTED. THE CUSTOMER CALLED BACK TO CONFIRM THE INACCURACIES AND PROVIDED ADDITIONAL EXAMPLES. THE CASE WAS FURTHER ESCALATED, AND THE CUSTOMER WAS INFORMED THAT THE SYSTEM SHOULD STABILIZE WITH CONTINUED USE. BY (B)(6) 2024, THE CUSTOMER WAS SATISFIED WITH THE SYSTEM'S PERFORMANCE, NOTING THAT DISCREPANCIES WERE MORE SIGNIFICANT WHEN GLUCOSE LEVELS WERE HIGHER BUT OVERALL, THE SYSTEM WAS ACCURATE. B4. DATE OF THIS REPORT 20 MARCH 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 20 MARCH 2025. H6. TYPE OF INVESTIGATION UPDATED TO 4121, H6. INVESTIGATION FINDINGS UPDATED TO 114, H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW. THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SENSONICS WAS MADE AWARE OF AN INCIDENT IN WHICH A USER REPORTED SENSOR INACCURACIES WHILE USING THE SYSTEM. THE USER PROVIDED THE FOLLOWING EXAMPLES: ·(B)(6) 2024: · BG: 65 MG/DL / SG: 211 MG/DL · BG: 86 MG/DL / SG: 258 MG/DL · BG: 86 MG/DL / SG: 261 MG/DL ADDITIONAL EXAMPLES PROVIDED: · (B)(6) 2024: · BG: 109 MG/DL / SG: NOT PROVIDED · BG: 141 MG/DL / SG: NOT PROVIDED · BG: 109 MG/DL / SG: NOT PROVIDED. NEXT-LEVEL SUPPORT ADVISED THE USER TO ALLOW THE SYSTEM A FEW MORE DAYS TO ADJUST AND TO ENTER ADDITIONAL CALIBRATIONS AS PROMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983798 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E274S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female