BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3021461 · Received March 26, 2013

    Report

    Report Number
    3004753838-2013-00072
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 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 IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013, TO REPORT THAT UPON REMOVAL OF SENSOR ON THE SAME DAY DUE TO DISCOMFORT, THE SENSOR WIRE WAS NOT VISIBLE ON THE UNDERSIDE OF SENSOR POD. THERE IS NO PORTION OF THE WIRE VISIBLE AT INSERTION SITE. PATIENT'S MOTHER DOES NOT BELIEVE THE WIRE IS UNDER THE PATIENT'S SKIN. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED THAT PATIENT'S DISCOMFORT HAD SUBSIDED, AND PATIENT IS IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124477 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5045585

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other