BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3171027 · Received June 14, 2013

    Report

    Report Number
    3004753838-2013-00158
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 20, 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 (B)(60 2013 DUE TO ADHESIVE ISSUE, THE SENSOR WIRE REMAINED PROTRUDING FROM THE INSERTION SITE. PATIENT'S MOTHER REMOVED THE WIRE FROM PATIENT'S SKIN. PATIENT EXPERIENCED NO DISCOMFORT AND REQUIRED NO MEDICAL INTERVENTION. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED PATIENT BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271454 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5065770

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other