BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2781496 · Received October 10, 2012

    Report

    Report Number
    3004753838-2012-00278
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT ON (B)(6) 2012, AROUND 10 AM, SHE HAD SUFFERED A HYPOGLYCEMIC EVENT WHILE USING AN EXPIRED SENSOR AND HAD LOST CONSCIOUSNESS WHILE SHOPPING AT A STORE. PARAMEDICS WERE CALLED. THEY ASSISTED PATIENT AND TRANSPORTED HER TO THE HOSPITAL. WHILE IN THE AMBULANCE, PATIENT'S BG WAS MEASURED AT 38 MG/DL AND PATIENT WAS ADMINISTERED 2 GLUCOSE GELS. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT PATIENT REPORTED THAT SHE WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-03 5036222

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O