BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4760278 · Received May 8, 2015

    Report

    Report Number
    3004753838-2015-14288
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    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

    (B)(4). IT WAS REPORTED THAT THE SENSOR WAS INSERTED IN AN UNAPPROVED SITE. THE DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM PATIENT CARE COORDINATOR ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE SENSOR WAS INSERTED ON (B)(6) 2015. THE SENSOR WAS INSERTED IN THE PATIENT'S ARM. AT THE TIME OF CONTACT, THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302492 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5197069

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO