BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2864087 · Received December 10, 2012

    Report

    Report Number
    3004753838-2012-00327
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 9, 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, SHE HAD SUFFERED A HYPOGLYCEMIC EPISODE WHILE CGM WAS STILL IN THE 2-HOUR-START-UP PERIOD, DURING WHICH CGM DOES NOT DISPLAY ANY GLUCOSE READINGS. PARAMEDICS WERE CALLED AND THEY TREATED PATIENT WITH GLUCOSE.AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other