BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2061021 · Received March 23, 2011

    Report

    Report Number
    3004753838-2011-00078
    Event Type
    Other
    Date Received
    March 23, 2011
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT SHE EXPERIENCED A FAILED SENSOR. UPON REMOVING THE SENSOR, PATIENT NOTICED THAT THE SENSOR WIRE REMAINED UNDERNEATH HER SKIN. SHE REPORTED THAT SHE COULD NOT SEE THE SENSOR WIRE BUT THAT SHE COULD FEEL IT UNDERNEATH HER SKIN. PATIENT REPORTED THAT SHE HAD SOME DISCOMFORT AT THE INSERTION SITE BUT REPORTED THAT THE INSERTION SITE LOOKED NORMAL.

    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 47 YR Other