BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2281636 · Received September 30, 2011

    Report

    Report Number
    3004753838-2011-00283
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 TECH SUPPORT ON (B)(6) 2011 TO REPORT THAT DURING INSERTION OF SENSOR, PT'S MOTHER WAS EXPERIENCING SOME ISSUES WITH THE SENSOR'S ADHESIVE PATCH. INSERTION WAS PAINFUL AND SOME BLOOD BECAME PRESENT AT THE SITE OF INSERTION. PT'S MOTHER DECIDED TO PULL OFF SENSOR AND NOTICED THAT SENSOR WIRE MISSING. PT'S MOTHER IS CONCERNED THAT WIRE MAY STILL BE UNDER PT'S SKIN. PT'S FATHER, A PHYSICIAN, APPLIED A BANDAGE ON INSERTION SITE AND DECIDED TO WAIT FOR PRESUMED BROKEN SENSOR TO WORK ITSELF OUT OF PT'S SKIN. DURING HER CALL TO DEXCOM TECH SUPPORT PT'S MOTHER REPORTS THAT PT WAS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5016811

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other