BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2900436 · Received January 7, 2013

    Report

    Report Number
    3004753838-2013-00002
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 10, 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 12/10/2012 TO REPORT THAT ON (B)(6) 2012, SHE HAD SUFFERED A HYPOGLYCEMIC EPISODE. PARAMEDICS WERE CALLED AND PATIENT WAS TREATED WITH AN 25 MG OF GLUCOSE.PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE SHE WAS EVALUATED AND RELEASED THE SAME DAY.AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7059 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O