BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2474231 · Received February 28, 2012

    Report

    Report Number
    3004753838-2012-00049
    Event Type
    Other
    Date Received
    February 28, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 3, 2012
    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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR ERROR, SENSOR WIRE WAS BROKEN. BROKEN WIRE WAS PROTRUDING FROM SKIN AND PATIENT WAS ABLE TO PULL IT OUT. PATIENT REPORTS NO ADDITIONAL COMPLICATIONS. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5032587

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other