BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2863595 · Received December 10, 2012

    Report

    Report Number
    3004753838-2012-00331
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 6, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S MOTHER CONTACTED DEXCOM ON (B)(6) 2012, TO REPORT THAT UPON REMOVAL OF SENSOR ON (B)(6) 2012, PATIENT EXPERIENCED IRRITATION, DISCHARGE AND DISCOMFORT AT THE SENSOR INSERTION SITE. PATIENT'S MOTHER ALSO REPORTED KNOTS UNDER THE PATIENT'S SKIN AT THE INSERTION SITE. PATIENT'S MOTHER CONSULTED A PHYSICIAN. THE PHYSICIAN PRESCRIBED AN ANTIBIOTIC TO BE APPLIED TO THE PATIENT'S SKIN AT THE SENSOR INSERTION SITE. AT THE TIME OF THE MOTHER'S CALL TO TECHNICAL SUPPORT, SHE REPORTS THAT PATIENT IS EXPERIENCING NO PAIN AT SENSOR SITE AND IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5042673

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other