BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3202018 · Received July 2, 2013

    Report

    Report Number
    3004753838-2013-00177
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 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 INTHE 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 SENSOR REMOVAL, DUE TO A FAILED SENSOR DURING WARM-UP PERIOD, PATIENT NOTICED THAT THE SENSOR APPEARED SHORTER THAN USUAL. PATIENT DOESN'T SEE OR FEEL ANYTHING AT THE INSERTION SITE AND IS NOT COMPLAINING OF ANY DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302729 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27 5059639

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other