BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 18567054 · Received January 23, 2024

    Report

    Report Number
    3009862700-2024-00173
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    December 10, 2020
    Report Date
    January 23, 2024
    Manufacturer
    SENSEONICS, INCORPORATED
    Product Code
    QCD
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW. BASED ON THE INVESTIGATION ANALYSIS, IT WAS OBSERVED THAT THERE WAS A TEMPORARY OFFSET CAUSED BY THE FINGERSTICK CALIBRATION ENTRY AT 6:34 AM CET, WHICH HAD LED TO TEMPORARY MISMATCH OF SENSOR GLUCOSE AND FINGERSTICK MEASUREMENT AT 3:22 PM CET. FOLLOWING THE TEMPORARY SENSOR INACCURACY EVENT AT 3:22 PM CET, THE NEXT FINGERSTICK CALIBRATION AT 4:41 PM CET WAS ACCEPTED AS A CALIBRATION AND HAD GOOD AGREEMENT WITH THE SENSOR READING. FURTHER ANALYSIS SHOWED THAT THE MEAN ABSOLUTE RELATIVE DIFFERENCE (MARD) IMPROVED IN THE WEEKS FOLLOWING THE EVENT.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT. USER SAID THE SENSOR READING WAS 7.8 MMOL/L AND TOOK SUGAR IMMEDIATELY AS HE WAS CLOSE TO HAVING A BLACK OUT, AND WASN'T ABLE TO MEASURE WITH A BLOOD GLUCOSE METER (BGM). USER SAID HE DID NOT RECEIVE ANY LOW GLUCOSE ALERT. USER DID NOT REQUIRE ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395229 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS, INCORPORATED 102208-804 117198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other