BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2023804 · Received March 9, 2011

    Report

    Report Number
    3004753838-2011-00059
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 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

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HIS RECEIVER DID NOT ALERT HIM DURING AN EXTREME LOW. PT WAS TAKING A NAP AT THE TIME OF THE EVENT AND BECAME UNCONSCIOUS. PATIENT'S DAUGHTER TESTED HIS BLOOD GLUCOSE AT 20 MG/DL AND GAVE HIM HONEY TO REVIVE HIM. PATIENT'S BG RAISED TO APPROX 45 MG/ DL. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5012875

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other