BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2133728 · Received June 17, 2011

    Report

    Report Number
    3004753838-2011-00189
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    PEDIATRIC PT IS A SUBJECT IN AN INDEPENDENT CLINICAL RESEARCH TRIAL SPONSORED BY A CHILDREN'S CLINIC. ON (B)(6) 2011, STUDY INVESTIGATOR INFORMED DEXCOM THAT PT EXPERIENCED A BROKEN SENSOR WIRE. PT'S MOTHER HAD CALLED THE CLINIC ON (B)(6) 2011 TO REPORT THAT PT FELT A LITTLE BIT OF PAIN AND TENDERNESS WHEN RIDING HIS 4 WHEELER. ON (B)(6) 2011, PT UNDERWENT AN ABDOMEN X-RAY THAT REVEALED A CURVY LINEAR RADIO DENSE STRUCTURE WITHIN THE RIGHT MID-ABDOMEN PROJECTING AT THE INFERIOR MARGIN OF THE LIVER. THE PT'S DOCTOR HAS GIVEN PT A REFERRAL FOR AN EVAL TO DETERMINE IF SURGERY WILL BE NECESSARY TO REMOVE DENSE STRUCTURE FROM ABDOMEN. PT WAS FINE AND EXPERIENCED NO REDNESS, SCARRING, OR SWELLING AT THE TIME OF REPORT TO DEXCOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015537

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other