BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 PROFESSIONAL SYSTEM

    MDR report key: 11993862 · Received June 14, 2021

    Report

    Report Number
    3004753838-2021-105894
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 16, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QII
    PMA / PMN Number
    K191833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889630 DEXCOM G6 PROFESSIONAL SYSTEM CONTINUOUS GLUCOSE MONITOR QII DEXCOM, INC. 9445-20 5281473

    Patients

    Seq Age Sex Outcome Treatment
    1