BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 5385696 · Received January 22, 2016

    Report

    Report Number
    3004753838-2016-00645
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 24, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CLINICIAN CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT A PATIENT EXPERIENCED DIABETIC KETOACIDOSIS (DKA) EVENTS. DATE OF EVENTS WERE NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD EPISODES OF DKA EVERY 2-3 MONTHS DUE TO RECURRENT URINARY TRACT INFECTIONS (UTI) AND PYELONEPHRITIS.

    Description of Event or Problem · 1

    CLINICIAN CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT A PATIENT EXPERIENCED DIABETIC KETOACIDOSIS (DKA) EVENTS. DATE OF EVENTS WERE NOT PROVIDED. DATE OF EVENTS ARE AN APPROXIMATION BASED OFF OF INFORMATION PROVIDED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS (DKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44934 ASKU MDS MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other