BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2428826 · Received January 19, 2012

    Report

    Report Number
    3004753838-2012-00019
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    December 24, 2011
    Report Date
    December 28, 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 UPON SENSOR REMOVAL, DUE TO SENSOR ERROR, SENSOR WIRE REMAINED INSERTED INSIDE PT'S SKIN. PT PROCEEDED TO PULL SENSOR OUT OF HIS SKIN. IMMEDIATELY FOLLOWING THE SENSOR FAILURE, INSERTION SITE WAS SLIGHTLY IRRITATED TO THE TOUCH, HOWEVER, AT THE TIME OF HIS MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT, PT WASN'T FEELING ANY MORE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5032602

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other