BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2612741 · Received June 4, 2012

    Report

    Report Number
    3004753838-2012-00155
    Event Type
    Other
    Date Received
    June 4, 2012
    Date of Event
    May 5, 2012
    Report Date
    May 5, 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 INSP 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO AN EARLY SENSOR SHUTOFF, PT COULDN'T LOCATE THE SENSOR WIRE AND IS CONCERNED THAT SENSOR MAY BE INSIDE OF HER SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, BESIDES REDNESS AT THE INSERTION SITE, PT REPORTS THAT SHE FEELS NOTHING UNDERNEATH HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5039462

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other