BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2220619 · Received July 14, 2011

    Report

    Report Number
    3004753838-2011-00215
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    PT'S PHYSICIAN CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT HAD EXPERIENCED A HYPOGLYCEMIC EPISODE WHILE OPERATING HER VEHICLE. PT RECALLS SEEING A GLUCOSE READING ERROR ON HER CGM BUT DECIDED TO DRIVE HER VEHICLE ANYWAY. PARAMEDICS WERE CALLED ON ACCIDENT SITE AND PT WAS TRANSPORTED TO HOSP WHERE HER BG WAS MEASURED TO BE BELOW MEASUREABLE POINT. PT NOW UNDERSTANDS NOT TO OPERATE A VEHICLE BEFORE TESTING HER BG. AT THE TIME OF HER CALL TO DEXCOM, PT WAS DOING FINE.

    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 48 YR Other