BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3152338 · Received June 7, 2013

    Report

    Report Number
    3004753838-2013-00142
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 21, 2013
    Report Date
    May 10, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON REMOVAL OF SENSOR ON (B)(6) 2013 DUE TO EARLY SENSOR FAILURE, PATIENT REPORTED THE WIRE WAS NOT VISIBLE ON THE UNDERSIDE OF THE SENSOR POD. AT THE TIME OF HIS CONTACT WITH THE INTERNATIONAL DISTRIBUTOR, PATIENT REPORTED BEING IN FINE CONDITION.DEXCOM ATTEMPTED TO ACQUIRE ADDITIONAL INFORMATION RELATED TO THE EVENT, TO NO AVAIL.ADDITIONAL INFORMATION WILL BE PROVIDED SHOULD A MORE COMPLETE VERSION OF THE COMPLAINT BECOME AVAILABLE TO DEXCOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252964 G4 CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other