BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2925841 · Received January 22, 2013

    Report

    Report Number
    3004753838-2013-00024
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 28, 2012
    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) 2012 TO REPORT THAT UPON REMOVAL OF SENSOR ON (B)(6) 2012 DUE TO BLEEDING, THE SITE CONTINUED TO BLEED FOR 5 HOURS. THE SENSOR HAD BEEN INSERTED EARLIER ON (B)(6) 2012. PATIENT REPORTED THAT HE HIT A BLOOD VESSEL DURING THE SENSOR INSERTION PROCESS. PATIENT'S WIFE DROVE HIM TO THE EMERGENCY ROOM ON (B)(6) 2012 WHERE PHYSICIAN GAVE HIM A SINGLE STITCH AT SENSOR INSERTION SITE. STITCH WAS REMOVED ON (B)(6) 2012. PATIENT STATED THAT HE IS ON BLOOD THINNERS. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED THAT HE HAD NO DISFIGUREMENT AND WAS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30181 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5045878

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other