BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9684845 · Received February 7, 2020

    Report

    Report Number
    3004753838-2020-013394
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 24, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000804
    PMA / PMN Number
    DEN170088
    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). INITIALLY THIS EVENT WAS REPORTED AS A REPORTABLE MALFUNCTION. UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE COMPLAINT. MFR 3004753838-2020-013394 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT SINCE THIS HAS NOW BEEN DEEMED NON-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROMPTED INITIAL SETUP ON ITS OWN ON THE MOBILE APP OCCURRED. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. DATA WAS EVALUATED AND CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT THE REPORT WAS SUBMITTED IN ERROR. PROMPTED INITIAL SETUP ON ITS OWN DID NOT OCCUR AND THEREFORE THE CRITERIA OF A REPORTABLE COMPLAINT IS NOT MET AS PER THE CODE OF FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143912 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. N/A 00386270000804

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR