BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2231568 · Received August 16, 2011

    Report

    Report Number
    3004753838-2011-00250
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    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 MOTHER EMAILED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 INITIALLY TO REPORT IRRITATION AT THE SITE OF INSERTION, THEN CALLED AGAIN ON (B)(6) 2011 TO REPORT THAT WHAT WAS INITIALLY REPORTED AS IRRITATION SEEMED TO BE AN IRRITATION DUE TO A BROKEN SENSOR. PATIENT'S MOTHER STATED THAT THE SENSOR WEAR SESSION STARTED WITH A PAINFUL SENSOR INSERTION. UPON REMOVAL OF SENSOR, 2 MM OF WIRE WAS STILL UNDER SKIN AND DRIED-UP BLOOD AS WELL AS A BUMP "THE SIZE OF A POPCORN KERNEL" WAS PRESENT AT THE INSERTION SITE. PATIENT'S MOTHER CONSULTED WITH PATIENT'S PHYSICIAN WHO ASSURED THEM THAT THE ISSUE WAS BENIGN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTS THAT INSERTION SITE IS NOT PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015532

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other