BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6662214 · Received June 22, 2017

    Report

    Report Number
    3004753838-2017-50718
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 28, 2017
    Report Date
    May 28, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED A BROKEN SENSOR WIRE RETAINED IN THE PATIENT'S SKIN. THE SENSOR WAS INSERTED AT THE ARM ON (B)(6) 2017. PATIENT'S MOTHER REPORTED THAT THE SENSOR FAILED DURING THE SENSOR SESSION. THE SENSOR WAS REMOVED AND THE SENSOR WIRE THAT WAS EXPOSED UNDER THE SENSOR POD WAS NOT THE SAME LENGTH AS THE PREVIOUS SENSOR WIRE. AN X-RAY EXAM WAS PERFORMED WHICH DID NOT CONFIRM ANY PORTION OF A SENSOR WIRE RETAINED UNDER THE PATIENT'S SKIN. DATE OF X-RAY EXAM IS UNKNOWN. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE SENSOR WAS INSERTED INTO THE ARM. LABELING INDICATES: 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

    A SENSOR (LOT # 5219869) WAS RETURNED FOR EVALUATION; HOWEVER IT IS NOT THE COMPLAINT SENSOR (LOT# 5222913). A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE SENSOR WIRE WAS ATTACHED TO THE SENSOR POD AND SEAL CARRIER AND WAS NOT BROKEN. THE SENSOR WIRE WAS INSERTED FARTHER THAN INTENDED IN HOUSING PUCK, RESULTING IN A SEEMINGLY SHORTER SENSOR WIRE. THE REPORTED EVENT OF A BROKEN SENSOR WIRE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441094 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 5222913 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other