BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2091142 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00142
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 21, 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 SHE EXPERIENCED INACCURACY IN CGM READINGS DURING AN EXTREME LOW ON TWO OCCASIONS (ABOUT 50-150 MG/DL DIFFERENCE BETWEEN CGM AND BG READINGS). ON (B)(6) 2011, PATIENT'S MOTHER FOUND THE PATIENT UNCONSCIOUS WHILE ASLEEP, TESTED HER BLOOD GLUCOSE (BG) AT 30 MG/DL, AND CALLED THE PARAMEDICS. UPON ARRIVAL, PARAMEDICS TESTED THE PATIENT'S BG AT 18 MG/DL AND ADMINISTERED A GLUCOSE IV. PATIENT REGAINED CONSCIOUSNESS BUT REFUSED TRANSPORT TO THE HOSPITAL. ON (B)(6) 2011, PATIENT RETURNED HOME FROM A NEARBY STORE (CGM 122 MG/DL PRIOR TO LEAVING THE STORE) ABOUT 10 MINUTES AWAY AND WAS FOUND UNCONSCIOUS ON THE KITCHEN FLOOR BY HER MOTHER SOON AFTER. MOTHER TESTED PATIENT'S BG AT 29 MG/DL AND CALLED THE PARAMEDICS, WHO ARRIVED AND TESTED PATIENT'S BG AT 18 MG/DL. PARAMEDICS ADMINISTERED A GLUCOSE IV, AND PATIENT REGAINED CONSCIOUSNESS BUT REFUSED TRANSPORT TO THE HOSPITAL. PATIENT REPORTED THAT SHE HAD TAKEN EXTRA BOLUSES OF INSULIN ON (B)(6) 2011. PATIENT WAS FULLY RECOVERED AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 1 OF 2 FOR THE COMPLAINT. SEE MDR #3004753838-2011-00143 FOR REPORT 2 OF 2.

    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 51 YR Other