BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2970347 · Received February 20, 2013

    Report

    Report Number
    3004753838-2013-00047
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    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 INTHE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON SENSOR REMOVAL, DUE TO SENSOR SESSION FAILURE, PATIENT'S FATHER NOTICED THAT A SMALL SENSOR FRAGMENT HAD REMAINED INSERTED IN THE PATIENT'S SKIN WHILE THE REST OF THE SENSOR WIRE WAS STILL ATTACHED TO THE POD'S UNDERSIDE. PATIENT'S FATHER WAS ABLE TO REMOVE PROTRUDING FRAGMENT OUT OF SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S FATHER REPORTED THAT PATIENT WAS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73396 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27 5047924

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other