BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2326529 · Received October 6, 2011

    Report

    Report Number
    3004753838-2011-00288
    Event Type
    Other
    Date Received
    October 6, 2011
    Date of Event
    August 27, 2011
    Report Date
    September 8, 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 DUE TO THE LOSS OF READINGS ON HER DEVICE, PT REMOVED SENSOR. UPON REMOVAL OF SENSOR, PT DISCOVERED THAT SENSOR HAD BECOME DETACHED AND WAS RESTING ON HER SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT WAS DOING FINE.

    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 59 YR Other