BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2160797 · Received July 5, 2011

    Report

    Report Number
    3004753838-2011-00205
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT AN INACCURACY IN CGM READING DURING A HYPOGLYCEMIC EPISODE, SEVERAL WEEKS AGO. PATIENT FELL ASLEEP AND WOKE UP TO PARAMEDICS WHO HAD ADMINISTERED HIM GLUCAGON AND AT WHICH POINT HIS BG WAS MEASURED AT 37 MG/DL WHILE CGM WAS READING 76 MG/DL. PATIENT WAS DOING BETTER AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT AND REPORTED NOT HAVING EXPERIENCED ANY HYPOGLYCEMIC EPISODES SINCE HIS LAST REPORTED EPISODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other