BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3230292 · Received July 16, 2013

    Report

    Report Number
    3004753838-2013-00187
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 17, 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 SENSOR WAS INADVERTENTLY PULLED OUT AND SESSION WAS TERMINATED. UPON SENSOR INSERTION SITE AND PATIENT'S SURROUNDINGS EXAMINATION, PATIENT NOTICED THAT SENSOR WIRE WAS MISSING. PATIENT DOESN'T REPORT ANY PAIN OR IRRITATION AT THE SENSOR'S INSERTION SITE AND WILL NOT SEEK MEDICAL INTERVENTION. PATIENT HAD BEEN WEARING HIS SENSOR FOR 10 CONSECUTIVE DAYS AT THE TIME THE SENSOR WAS ABRUPTLY PULLED OUT. EXTENDED USE OF SENSOR BEYOND 7 DAYS IS OFF-LABEL. SINCE PATIENT IS UNABLE TO PROVIDE CGM DATA, DEXCOM IS SEEKING FOR PATIENT TO RETURN HIS CGM IN ORDER FOR DEXCOM TO INVESTIGATE THE DATA AROUND THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328637 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27 5057588

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other