BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2625779 · Received June 14, 2012

    Report

    Report Number
    3004753838-2012-00168
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    May 20, 2012
    Report Date
    May 21, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT SHE BELIEVES THAT SENSOR HAD BROKEN INSIDE HER SKIN UPON SENSOR REMOVAL. PT STATES THAT THE INSERTION AREA IS RED, SORE AND BUMPY HOWEVER PT DOES NOT SEE NOR FEEL THE SENSOR IN HER SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTED THAT SHE 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 5038094

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other