BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6401900 · Received March 14, 2017

    Report

    Report Number
    3004753838-2017-15919
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 16, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    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, OF AN INTRODUCER NEEDLE BROKEN FROM THE APPLICATOR DURING INSERTION OF THE SENSOR. THE INSERTION SITE WAS AT THE BACK. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF AN INTRODUCER NEEDLE DETACHED FROM THE APPLICATOR COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED. THE SENSOR WAS INSERTED INTO THE BACK. 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

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THE NEEDLE, PUSH ROD, AND PLUNGER IS DETACHED FROM THE APPLICATOR BODY. THE NEEDLE IS EXPOSED AND BENT. THE REPORTED EVENT OF A BROKEN NEEDLE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A PHOTOGRAPH WAS RECEIVED FOR EVALUATION. IT WAS OBSERVED THAT THE NEEDLE WAS PRESENT AND INTACT, HOWEVER, IT HAS BEEN REMOVED FROM THE APPLICATOR ALONG WITH THE PLUNGER AND BODY CAP. BASED ON THE INFORMATION AND PHOTO PROVIDED BY THE PATIENT, THE REPORTED EVENT OF A BROKEN NEEDLE CANNOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185767 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 5215257 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR