BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2693616 · Received August 8, 2012

    Report

    Report Number
    3004753838-2012-00226
    Event Type
    Other
    Date Received
    August 8, 2012
    Date of Event
    May 15, 2012
    Report Date
    July 13, 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

    ON (B)(6) 2012, PATIENT'S FATHER REPORTED TO DEXCOM TECHNICAL SUPPORT THAT SENSOR WIRE APPEARED TO HAVE BROKEN IN PATIENT'S ARM. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other