BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1616866 · Received February 25, 2010

    Report

    Report Number
    3004753838-2010-00010
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    April 21, 2009
    Report Date
    April 22, 2009
    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 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

    MINOR PATIENT ORIGINALLY BELIEVED THAT THE SENSOR WIRE BROKE DURING REMOVAL. FOLLOWING A CALL WITH DEXCOM TECH SERVICES, PATIENT'S MOTHER DETERMINED THAT NO PART OF THE WIRE REMAINED IN THE PATIENT AND THE FULL SENSOR WAS IN FACT PRESENT IN THE TRASH. THE DISCARDED SENSOR WAS NOT RETURNED BY THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other