BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS GLUCOSE MONITOR

    MDR report key: 8488252 · Received April 5, 2019

    Report

    Report Number
    3004753838-2019-032226
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR 3004753838 - 2019 - 032226 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT THE LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279864 CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR