BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2255162 · Received September 16, 2011

    Report

    Report Number
    3004753838-2011-00253
    Event Type
    Other
    Date Received
    September 16, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 1, 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 UPON REMOVAL OF SENSOR WIRE DUE TO SENSOR FAILURE, SENSOR WIRE REMAINED INSERTED IN HIS SKIN. PT WAS ABLE TO PULL PROTRUDING SENSOR OUT OF HIS SKIN WITH HIS OWN FINGERS. DURING HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS FEELING NO CONCERN AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015540

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other