BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1952646 · Received January 4, 2011

    Report

    Report Number
    3004753838-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 6, 2010
    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) 2010, TO REPORT THAT SHE EXPERIENCED AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW (CGM >200 MG/DL, FINGERSTICK 28,33 MG/DL). PATIENT REPORTED THAT SHE PASSED OUT, AND PARAMEDICS WERE CALLED. PATIENT'S SON GAVE HER GLUCAGON, AND PATIENT REFUSED TO GO TO THE HOSPITAL. PATIENT WAS OKAY AT THE TIME OF HER 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 Other