BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2092918 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00151
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED A POSSIBLE BROKEN SENSOR WIRE. TEN DAYS AFTER REMOVING HER SENSOR, PT FELT UNEXPLAINABLE PAIN AT THE INSERTION SITE AND WONDERED IF THE WIRE MAY HAVE BROKEN OFF. PT STATED THAT THE SENSOR HAD LOOKED "PRETTY NORMAL" AFTER REMOVAL. PT REPORTED NO BRUISING OR IRRITATION. DURING A F/U CALL ON (B)(6) 2011, PT CLARIFIED THAT SHE NEVER SAW A BROKEN WIRE AT THE SITE OR NOTICED THAT THE WIRE APPEARED SHORTER. PT EXPERIENCED SOME SHARP PAIN ON AND OFF, BUT IT HAD SINCE GONE AWAY. DEXCOM TECHNICAL SUPPORT MADE ANOTHER F/U CALL ON (B)(6) 2011. PT REPORTED THAT SHE WAS UNABLE TO CONFIRM WHETHER THE WIRE WAS UNDER THE SKIN. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT EXPERIENCED NO PROBLEMS SINCE THE INCIDENT.

    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 60 YR Other