BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1952938 · Received January 4, 2011

    Report

    Report Number
    3004753838-2011-00010
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 23, 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 TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT HE EXPERIENCED A FAILED SENSOR APPROX 20 MINS AFTER INSERTION. UPON REMOVING THE SENSOR, PT NOTICED THAT THE SENSOR WIRE WAS LEFT UNDER HIS SKIN. PT REPORTED THAT HE WAS ABLE TO REMOVE THE WIRE FROM HIS SKIN AND EXPERIENCED NO DISCOMFORT AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5012427

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other