BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8921840 · Received August 22, 2019

    Report

    Report Number
    3004753838-2019-61558
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 22, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 ON (B)(6) 2019. IT WAS REPORTED THAT THE READINGS BETWEEN THE CGM AND BG METER HAD A 100MG/DL POINT DIFFERENCE. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714873 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-46 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR