BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 11774599 · Received May 4, 2021

    Report

    Report Number
    3009862700-2021-00068
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 5, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS DISCHARGED ON (B)(6) 2021. USER STATES THAT THE TRANSMITTER DID ALERT HIGH READINGS. INVESTIGATION SHOWS THAT CUSTOMER WAS HYPERGLYCEMIC IN DAYS LEADING UP TO THE EVENT. ALTHOUGH THE INVESTIGATION COULDN'T CONFIRM THE HIGH GLUCOSE ALERT IN DMS, THE CUSTOMER DID CONFIRM THAT HE RECEIVED HIGH GLUCOSE ALERT. INVESTIGATION FOUND NO EVIDENCE OF MALFUNCTION AND SYSTEM PERFORMED AS INTENDED. H6: INVESTIGATION FINDINGS UPDATED TO 213. H6: INVESTIGATION CONCLUSIONS UPDATED TO 44.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON APRIL 05TH 2021, SENSEONICS WAS MADE AWARE OF ADVERSE EVENT WHERE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 DUE TO DIABETIC KETOACIDOSIS AND WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670252 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-500 116514 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization