BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3903422 · Received June 30, 2014

    Report

    Report Number
    3004753838-2014-05735
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON AN UNKNOWN DATE, THEY HAD EXPERIENCED A HYPOGLYCEMIC EVENT WHILE WEARING THE DEXCOM CGM SYSTEM WHICH REQUIRED MEDICAL INTERVENTION AND TRANSPORTATION TO THE HOSPITAL. THE PATIENT RECEIVED INTRAVENOUS THERAPY AND WAS RELEASED THE SAME DAY FROM THE HOSPITAL. THE PATIENT REPORTED FEELING FINE AT THE TIME OF THE CALL, AND THAT SHE RECALLED THE DEVICE ALARMING APPROPRIATELY TO WARN HER OF THE LOW. PATIENT ALSO REPORTED DISPOSING OF HER CGM SYSTEM SINCE THE INCIDENT. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED NO FURTHER INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379278 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 8219-16

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other