BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2914548 · Received January 14, 2013

    Report

    Report Number
    3004753838-2013-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 16, 2012
    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) 2012 TO REPORT THAT HER SENSOR BECAME DISLODGED FROM HER BODY ON (B)(6) 2012 AFTER SHE HIT THE SITE AGAINST A CHAIR. PATIENT BELIEVES A PORTION OF THE SENSOR WIRE REMAINED UNDER HER SKIN. PATIENT CONSULTED HER NEIGHBOR, WHO IS A NURSE. THE NURSE ATTEMPTED TO REMOVE THE WIRE, WITHOUT AVAIL. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED NO SIGNS OF INFECTION, AND THAT SHE IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19953 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5044234

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other