BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM FOLLOW APP

    MDR report key: 9775566 · Received March 2, 2020

    Report

    Report Number
    3004753838-2020-020347
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    January 17, 2020
    Report Date
    March 2, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. VOLUNTARY MEDWATCH REPORT NUMBER MW-5092455.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE PATIENT¿S CAREGIVER STATED THEY WERE NOT ABLE TO VIEW DATA ON THE FOLLOW APP WHICH RESULTED IN THE PATIENT MISSING A HYPOGLYCEMIC EVENT. THEY STATED THAT THEY WERE ABLE TO IDENTIFY, REVERSE AND STABILIZE THE EVENT BEFORE A SERIOUS INJURY OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO PRODUCT WAS PROVIDED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238660 DEXCOM FOLLOW APP CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other