BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3243889 · Received July 23, 2013

    Report

    Report Number
    3004753838-2013-00202
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 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 ON DATE OF REPORT, UPON REMOVAL OF SENSOR, SHE BELIEVES THE TIP OF THE WIRE REMAINED UNDER PATIENT'S SKIN. NO PORTION OF THE WIRE WAS VISIBLE AT SENSOR INSERTION SITE. SHE REPORTS A LIGHT RED, SCRATCH-LIKE LINE AT THE SENSOR INSERTION SITE. PATIENT EXPERIENCED NO DISCOMFORT AND REQUIRED NO MEDICAL INTERVENTION. AT THE TIME OF THE CALL TO TECHNICAL SUPPORT, PATIENT WAS REPORTED TO BE IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342154 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5058593

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other