BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8621170 · Received May 17, 2019

    Report

    Report Number
    3004753838-2019-42748
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    February 28, 2019
    Report Date
    May 17, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE RECEIVED BY MANUFACTURER SHOULD HAVE REFLECTED A DATE OF (23-APR-2019).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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) 2019. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413299 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-46 NI

    Patients

    Seq Age Sex Outcome Treatment
    1