BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1951144 · Received December 29, 2010

    Report

    Report Number
    3004753838-2010-00216
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 30, 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

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010, TO REPORT THAT SHE EXPERIENCED A BROKEN SENSOR WIRE SEVEN DAYS AFTER INSERTION. PT REPORTED THAT, UPON REMOVING THE SENSOR, SHE NOTICED THERE WAS NO WIRE ATTACHED. PT REPORTED THAT SHE SAW THE WIRE PROTRUDING FROM HER SKIN AND TRIED TO PULL IT OUT. THE WIRE BROKE AS SHE PULLED IT, LEAVING THE DISTAL FRAGMENT UNDERNEATH HER SKIN. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT.

    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 45 YR Other