BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2326531 · Received October 6, 2011

    Report

    Report Number
    3004753838-2011-00290
    Event Type
    Other
    Date Received
    October 6, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 9, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR FAILURE, SENSOR WAS NO LONGER PRESENT. PT BELIEVES THAT SENSOR WIRE MAY HAVE BROKEN UNDER HIS SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS FEELING FINE AND NOT HAVING ANY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5020796

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other