BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2464114 · Received February 14, 2012

    Report

    Report Number
    3004753838-2012-00037
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    December 31, 2010
    Report Date
    January 20, 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 SHE HAS BEEN EXPERIENCING BROKEN SENSORS ISSUES. PT USUALLY PROCEEDS TO REMOVE SENSORS OUT OF HER SKIN WITH HER OWN FINGERS. PT HAS REPORTED THE ISSUE TO HER ENDOCRINOLOGIST. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT WAS FEELING FINE BUT WAS NOT WEARING CGM ANYMORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other