BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2671086 · Received July 19, 2012

    Report

    Report Number
    3004753838-2012-00206
    Event Type
    Other
    Date Received
    July 19, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 25, 2012
    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, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON REMOVAL OF SENSOR DUE TO LOSS OF CALIBRATION, THE SENSOR WIRE WAS VISIBLE UNDERNEATH PATIENT'S SKIN. THE SENSOR HAD BEEN INSERTED IN PATIENT'S ARM. NO MEDICAL INTERVENTION WAS REQUIRED. AT THE TIME OF THE CALL TO TECHNICAL SUPPORT, THE PATIENT WAS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5039780

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other