BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3033940 · Received April 3, 2013

    Report

    Report Number
    3004753838-2013-00083
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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 UPON REMOVAL OF SENSOR ON DATE OF REPORT DUE TO END OF SENSOR SESSION, THE SENSOR WIRE WAS NOT VISIBLE ON THE UNDERSIDE OF THE SENSOR POD. PATIENT REPORTED A SMALL RED MARK AT INSERTION SITE AND CLAIMED TO FEEL SOMETHING BELOW HER SKIN. NO PORTION OF THE WIRE WAS VISIBLE AT INSERTION SITE. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION. PATIENT EXPERIENCED NO DISCOMFORT, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136072 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5046158

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other