BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2107868 · Received May 24, 2011

    Report

    Report Number
    3004753838-2011-00164
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 13, 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 ABSCENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT A FAILED SENSOR. WHILE PATIENT WAS REMOVING THE SENSOR, THE SENSOR WIRE BROKE. THE WIRE WAS VISIBLE, AND PATIENT PULLED IT OUT OF THE INSERTION SITE. PATIENT DID NOT EXPERIENCE ANY PAIN OR DISCOMFORT, AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT WAS FINE AT THE TIME OF HIS WIFE'S 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 5015564

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other