BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2231616 · Received August 16, 2011

    Report

    Report Number
    3004753838-2011-00247
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 23, 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 THAT HE HAD EXPERIENCED A HYPOGLYCEMIC EPISODE. HIS BG/CGM WAS 29/70 MG/DL. PATIENT INGESTED SOME JUICE AND GLUCOSE TABLETS BUT FELT WEAK AND CONFUSED SO HE CALLED THE PARAMEDICS. BY THE TIME THE PARAMEDICS ARRIVED, PATIENT WAS STARTING TO FEEL BETTER AND PARAMEDICS DID NOT HAVE TO TREAT. PATIENT'S BG WAS TESTED TO BE BACK IN THE APPROXIMATELY 50 MG/DL. PATIENT REPORTS FEELING FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT.

    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 54 YR Other