BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1692462 · Received May 12, 2010

    Report

    Report Number
    3004753838-2010-00089
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 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 TECH SUPPORT ON (B)(6) 2010 TO REPORT THAT SHE EXPERIENCED AN ERROR MESSAGE FOR APPROX 5 HOURS FOLLOWING SENSOR INSERTION. WHEN PT REMOVED THE FAILED SENSOR, SHE REPORTED THAT A PORTION OF THE SENSOR WIRE WAS RETAINED IN HER SKIN. PT WAS ABLE TO REMOVE THE RETAINED DISTAL FRAGMENT WITH TWEEZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5007081

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other