BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3021462 · Received March 26, 2013

    Report

    Report Number
    3004753838-2013-00073
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 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 IN THE 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 REMOVAL OF SENSOR ON (B)(6) 2013, DUE TO SENSOR FAILURE, PATIENT NOTICED THE SENSOR WIRE PROTRUDING FROM HIS SKIN AT INSERTION SITE. PATIENT REMOVED THE WIRE FROM HIS SKIN. DEXCOM REQUESTED DATA DOWNLOAD FOR INVESTIGATIVE PURPOSES. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123108 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5047528

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other