BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 12803936 · Received November 12, 2021

    Report

    Report Number
    3009862700-2021-00138
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    October 20, 2021
    Report Date
    October 20, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491021441
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 INVESTIGATION COULDN'T CONFIRM THE REPORTED INACCURACY BASED ON THE CUSTOMER-PROVIDED BG/SG VALUES AND TIME. HOWEVER, THE REVIEW OF THE CALIBRATIONS REVEALED THAT THE CUSTOMER WAS LIKELY USING SG VALUES FOR CALIBRATION OF THE SYSTEM, WHICH MIGHT HAVE LED TO THE DISCREPANCIES EXPERIENCED BY THE USER. NO FURTHER COMMUNICATION WITH THE USER WAS POSSIBLE DUE TO LACK OF RESPONSE FROM THE USER. PER CASE NOTES, USER WENT TO THE EMERGENCY ROOM (ER) WHERE THE DOCTORS CHECKED THE BG AND SAID EVERYTHING WAS FINE. USER WENT TO THE EMERGENCY ROOM (ER) BUT NO TREATMENT OR MEDICATION WAS NECESSARY AS THE BLOOD GLUCOSE (BG) WAS IN NORMAL RANGE. USER IS FEELING GOOD. NO FURTHER RESOLUTION WAS NECESSARY FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE CUSTOMER STATED THAT SENSOR IS GIVING LOW RESULTS FOR A WEEK,BUT CUSTOMER DECIDED TO GO TO EMERGENCY ROOM. USER RECEIVED A LOW GLUCOSE ALERT ON THE MOBILE DEVICE. IN THE EMERGENCY ROOM,CUSTOMER BLOOD SUGAR WAS CHECKED AND THE DOCTORS SAID EVERYTHING WAS OKAY AND CUSTOMER WAS SENT TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705098 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-500 123501 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female