BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6415113 · Received March 17, 2017

    Report

    Report Number
    3004753838-2017-15946
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 11, 2017
    Report Date
    February 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CLASSIFICATION CODE POQ IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 02/15/2017, THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED A DETACHED SENSOR WIRE. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2017. PATIENT'S MOTHER INSERTED THE SENSOR THE AT NIGHT AND IN THE MORNING NOTICED THAT THERE WERE NO READINGS. PATIENT'S MOTHER REMOVED THE SENSOR AND DID NOT SEE THE SENSOR WIRE. ON (B)(6) 2017, THE PATIENT WENT TO THE SCHOOL NURSE COMPLAINING OF ABDOMINAL DISCOMFORT. THE SCHOOL NURSE CALLED THE PATIENT'S PARENT AND ADVISED THAT THEY COME AND REMOVE THE WIRE FROM THE PATIENT'S ABDOMEN. THE PATIENT WAS BROUGHT TO URGENT CARE WHERE THE PHYSICIAN WAS ABLE TO SQUEEZE AND MANIPULATE THE SKIN IN ORDER TO VISUALIZE THE SENSOR WIRE. THE PHYSICIAN SURGICALLY REMOVED THE SENSOR WIRE AND USED LOCAL ANESTHETIC ON THE PATIENT. PATIENT WAS DISCHARGED AFTER SENSOR WIRE REMOVAL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A SENSOR WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE WIRE IS MISSING FROM THE SENSOR POD AND SEAL CARRIER. DUE TO THE MISSING SENSOR WIRE, THE SENSOR WIRE IS CONSIDERED DETACHED. THE CUSTOMER'S COMPLAINT OF A DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194913 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other