BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1883280 · Received October 20, 2010

    Report

    Report Number
    3004753838-2010-00188
    Event Type
    Other
    Date Received
    October 20, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 27, 2010
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010, TO REPORT THAT PT EXPERIENCED A FAILED SENSOR 3 DAYS AFTER INSERTION. HE REPORTED THAT, UPON REMOVING THE SENSOR, THE WIRE WAS NOT PRESENT. NO MEDICAL ATTENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HIS FATHER'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 5009018

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other