BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8015834 · Received October 29, 2018

    Report

    Report Number
    3004753838-2018-131939
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    September 30, 2018
    Report Date
    March 6, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE UPPER BUTTOCKS ON (B)(6) 2018. IT WAS REPORTED THAT PATIENT WAS UNDER 2 YEARS OLD. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED FOR EVALUATION, DATA REVIEW CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. LABELING INDICATES: THE DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (DEXCOM G6 SYSTEM) IS A REAL TIME, CONTINUOUS GLUCOSE MONITORING DEVICE INDICATED FOR THE MANAGEMENT OF DIABETES IN PERSONS AGE 2 YEARS AND OLDER.

    Description of Event or Problem · 1

    AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS SUPPLEMENTAL MEDWATCH WAS SUBMITTED IN ERROR. PLEASE DISREGARD INFORMATION SUBMITTED IN THE FIRST SUPPLEMENTAL MEDWATCH OF 3004753838-2018-131939.

    Description of Event or Problem · 1

    A SENSOR WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THE APPLICATOR HAD A BENT NEEDLE AND BENT PUSHROD, INDICATING A NEEDLE OUT DEPLOYMENT FAILURE. THE REPORTED EVENT OF A NEEDLE RETRACTION ISSUE WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855023 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 5239285 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO