BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 19231985 · Received May 2, 2024

    Report

    Report Number
    3004464228-2024-16097
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 26, 2024
    Report Date
    July 23, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000206
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION H6 - ADVERSE EVENT PROBLEM MEDICAL DEVICE PROBLEM CODE FROM: A26 INSUFFICIENT INFORMATION TO: A110701 LOSS OF DATA.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROVIDER (HCP) THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS REPORTEDLY UNABLE TO VIEW BASAL INSULIN INDICATED ON TOTAL DOSES ON THE GLOOKO REPORT. ADDITIONAL INFORMATION REGARDING THE INCIDENT WAS SOLICITED BUT IS UNAVAILABLE. IF ADDITIONAL INFORMATION IS PROVIDED AND/OR RESULTS FROM RETURN PRODUCT ANALYSIS INVESTIGATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858492 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001194 10385083000206

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Hospitalization