BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEX COM SEVEN - SYSTEM SENSOR

    MDR report key: 1230131 · Received November 12, 2008

    Report

    Report Number
    MW5008980
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 31, 2008
    Manufacturer
    DEX COM
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE DEX COM SENSOR WAS INSERTED INTO THE LEFT LOWER QUADRANT OF THE ABDOMEN. TWO HOURS LATER, THE DEVICE ALARMED AND ENDED THE SESSION. THE SENSOR UNIT WAS REMOVED LATER THAT EVENING, BUT THE SENSOR WIRE WAS NOT ATTACHED. UPON INSPECTION OF SITE, THE SENSOR WIRE WAS FELT UNDER THE SKIN. ANOTHER SENSOR WAS INSERTED ON RIGHT LOWER QUADRANT OF ABDOMEN. ON TWO DAYS LATER, THE DEVICE ALARMED AND ENDED THE SESSION. WHEN THE MOTHER REMOVED SENSOR UNIT, PART OF THE SENSOR WIRE REMAINED UNDER THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEX COM SEVEN - SYSTEM SENSOR SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS DEX COM 080602411

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R