BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3152452 · Received June 7, 2013

    Report

    Report Number
    3004753838-2013-00138
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 9, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013, 5 DAYS AFTER INSERTION, PATIENT REMOVED SENSOR DUE TO SENSOR ERROR. UPON REMOVAL OF SENSOR, PATIENT WAS CONCERNED THAT THE SENSOR WIRE MAY HAVE BROKEN UNDER HIS SKIN. THERE WAS NO INDICATION OF ANY PORTION OF THE WIRE AT INSERTION SITE. PATIENT EXPERIENCED NO DISCOMFORT AND REQUIRED NO MEDICAL INTERVENTION.AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252718 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other