BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2366426 · Received December 1, 2011

    Report

    Report Number
    3004753838-2011-00335
    Event Type
    Other
    Date Received
    December 1, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 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 INSP 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 SENSOR REMOVAL DUE TO A SENSOR FAILURE, PT NOTICED THAT SENSOR WIRE WAS SHORTER THAN EXPECTED. PT REPORTS NOT FEELING ANY DISCOMFORT NOR SEEING ANY SENSOR PROTRUDING FROM SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS NO ISSUES AT ALL AT THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5021884

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other