BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2602387 · Received June 5, 2012

    Report

    Report Number
    3004753838-2012-00159
    Event Type
    Other
    Date Received
    June 5, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 10, 2012
    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 FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO A PAINFUL SENSOR SESSION, PT'S FATHER NOTICED THAT SENSOR WIRE WAS PROTRUDING FROM SKIN. WHEN THE SENSOR WAS REMOVED THE SKIN WAS RED AND PUFFY. ONE DAY LATER, THE SKIN HAD RETURNED TO NORMAL. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT'S FATHER REPORTED THAT PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5032591

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other