BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3033964 · Received April 3, 2013

    Report

    Report Number
    3004753838-2012-00382
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013, TO REPORT THAT APPROXIMATELY A YEAR PRIOR TO REPORT DATE, SHE DEVELOPED AN ALLERGIC REACTION TO AN ADHESIVE PRODUCT (MASTISOL) USED IN CONJUNCTION WITH HER CGM SENSORS. THE REACTION OCCURED ON THE PORTION OF HER SKIN COVERED BY THE SENSOR ADHESIVE. PATIENT BECAME CONCERNED THAT HER REACTION MAY BE TO THE SENSOR ADHESIVE IN ADDITION TO THE MASTISOL, AND CONSULTED HER PHYSICIAN. THE PHYSICIAN DETERMINED THE CAUSE OF THE REACTION TO BE RELATED TO BOTH THE MASTISOL AND THE SENSOR ADHESIVE, AND PRESCRIBED A CREAM TO USE ON THE RASH. PATIENT BELIEVES THAT THE MASTISOL MAY HAVE TRIGGERED OR CONTRIBUTED TO HER REACTION TO THE SENSOR ADHESIVE. PATIENT REPORTS THAT SHE CONTINUES TO EXPERIENCE A RASH AT THE SITE OF THE SENSOR ADHESIVE, WHICH TAKES 4-6 WEEKS TO HEAL FULLY. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED NO PERMANENT SKIN DISCOLORATION OR DISCOMFORT. DURING A FOLLOW-UP CALL WITH PATIENT ON (B)(6) 2013, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136094 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other