BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8070116 · Received November 14, 2018

    Report

    Report Number
    3004753838-2018-141481
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 17, 2018
    Report Date
    October 17, 2018
    Manufacturer
    QBJ
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION AND PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908677 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ QBJ 9500-45 5243461 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR