BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 18318491 · Received December 13, 2023

    Report

    Report Number
    3009862700-2023-00645
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    September 21, 2021
    Report Date
    December 13, 2023
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491023087
    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 ANALYSIS, IT WAS OBSERVED THAT THERE WAS NO COMMUNICATION BETWEEN THE SENSOR READINGS AND FINGERSTICK MEASUREMENTS FROM 4:23 PM CET UNTIL 5:22 PM CET. DURING THIS TIME THE SYSTEM ASSERTED MULTIPLE 'NO SENSOR DETECTED' ALERTS AND SINCE THERE WAS NO SENSOR READINGS TAKEN BETWEEN 4:23 PM CET AND 5:22 PM CET, NO GLUCOSE RELATED ALERTS WERE ASSERTED. HOWEVER, THE SYSTEM DID ASSERT A PREDICTIVE LOW GLUCOSE ALERT AT 4:22 PM CET TO ALERT THE USER OF THE UPCOMING HYPO EVENT. THERE WAS NO MALFUNCTION OF THE SYSTEM AND NO FURTHER INVESTIGATION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PATIENT EXPERIENCED A HYPOGLYCEMIA EVENT DUE TO INACCURACIES IN SENSOR READINGS. USER HAD SYMPTOMS SUCH AS SWEATING AND TREMBLING. USER COMPLAINED TO HAVE NOT RECEIVED LOW GLUCOSE ALERTS. SENSOR GLUCOSE WAS 81 MG/DL. BLOOD GLUCOSE VALUE WAS NOT PROVIDED AS USER DID NOT TAKE BG READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261857 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-750 121946 00817491023087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other