BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2105330 · Received May 2, 2011

    Report

    Report Number
    3004753838-2011-00127
    Event Type
    Other
    Date Received
    May 2, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT A FAILED SENSOR ONE HOUR AFTER INSERTION. UPON REMOVING THE SENSOR, SHE NOTICED THAT THE SENSOR APPEARED TO BE KINKED OR POSSIBLY SHORTER. PATIENT CONFIRMED THERE WAS NO WIRE VISIBLE AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PATIENT WAS FINE WITH NO ISSUES AT THE SITE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT. DEXCOM TECHNICAL SUPPORT MADE A FOLLOW-UP CALL TO PATIENT ON (B)(6) 2011. PATIENT REPORTED THAT BOTH SHE AND THE SITE WERE "PERFECTLY FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5012433

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other