BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1842558 · Received September 13, 2010

    Report

    Report Number
    3004753838-2010-00172
    Event Type
    Other
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    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

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT A FAILED SENSOR FOLLOWING INSERTION. PT REPORTED THAT THE SENSOR WIRE APPEARED SHORTER THAN NORMAL FOLLOWING REMOVAL. PT WAS CONCERNED THAT THE SENSOR WIRE MIGHT HAVE BROKEN OFF UNDER HER SKIN. PT'S HUSBAND EXAMINED THE WIRE AND BELIEVED THAT IT WAS ONLY KINKED AND THERE WAS NO RETAINED DISTAL FRAGMENT. PT HAS NOT RETURNED THE SUSPECTED BROKEN SENSOR TO DEXCOM FOR EVALUATION. DEXCOM IS REPORTING THIS COMPLAINT AS A POSSIBLE BROKEN SENSOR UNTIL LABORATORY EVALUATION CAN CONFIRM OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5009704

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other