BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 7155881 · Received December 29, 2017

    Report

    Report Number
    3004753838-2017-115795
    Event Type
    Death
    Date Received
    December 29, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ADDITIONAL DEATH REPORT IS BEING SUBMITTED UNDER MFR 3004753838-2017-115794.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017, VIA SOCIAL MEDIA, THAT TWO YOUNG DEXCOM USERS PASSED AWAY. THE REPORTER'S POST INDICATED THAT THE VOLUME ON THE RECEIVERS IS NOT AS LOUD AS THE VOLUME ON MOBILE DEVICES AND THAT SHE WAS AWARE OF TWO USERS WHO HAD EXPERIENCED LOW BLOOD GLUCOSE AND WERE NOT AWOKEN BY THE DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM). CONTACT WITH THE REPORTER WAS MADE ON (B)(6) 2017, AND IT WAS INDICATED THAT THE REPORTER DID NOT KNOW THE MEN PERSONALLY, BUT THAT SHE CAME ACROSS THE INFORMATION WHEN BROWSING THE INTERNET AND READING ARTICLES. THE REPORTER INDICATED THAT THE WEBSITE DID NOT STATE THAT THE DEATHS WERE DUE TO THE CGM NOT WORKING PROPERLY. THE REPORTER STATED THAT SHE WAS A NURSE AND CERTIFIED DIABETES EDUCATOR AND COULD IMAGINE HOW THE LOW VOLUME OF THE RECEIVER COULD HAVE LED TO THE DEATHS. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934969 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O