BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3177941 · Received June 19, 2013

    Report

    Report Number
    3004753838-2013-00165
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN INTHE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON SENSOR REMOVAL THE SENSOR HAD REMAINED INSIDE HIS SKIN AT THE INSERTION SITE WHICH PATIENT PROCEEDED TO PULL OUT. AT THE TIME OF CALL TO DEXCOM TECHNICAL SUPPORT PATIENT WAS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279051 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-03 5048521

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other