BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2092914 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00141
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 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, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED A BROKEN SENSOR WIRE. UPON REMOVING THE SENSOR, PT'S MOTHER NOTICED THAT THE SENSOR WIRE WAS ALMOST BROKEN IN HALF. THERE WAS NO WIRE BROKEN UNDER OR PROTRUDING FROM THE SKIN. PT'S MOTHER REPORTED BLOOD AT THE INSERTION SITE THAT MAY HAVE BEEN CAUSED BY THE PT BUMPING INTO THE SENSOR. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HER MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5013122

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other