BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5

    MDR report key: 16487618 · Received March 2, 2023

    Report

    Report Number
    MW5115439
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 28, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OMNIPOD 5 APP ON SAMSUNG S21 WAS PREVIOUSLY WORKING WITHOUT PROBLEMS. DUE TO INSULET'S BADLY DEVELOPED AND BUGGY SOFTWARE, IT SUDDENLY STOPPED WORKING ON (B)(6) 2023. THE ERROR MESSAGE IS: "THIS DEVICE DOES NOT MATCH THE MANUFACTURER CONFIGURATION. IT CANNOT BE USED WITH OMNIPOD 5." MY DEVICE IS ADVERTISED AS COMPATIBLE ON INSULETS WEBSITE. IT HAS BEEN WORKING WITHOUT PROBLEM, AND NOTHING WAS CHANGED ABOUT MY DEVICE TO CAUSE IT TO FAIL. NO SOFTWARE WAS INSTALLED AND NO OS UPDATES WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705922 OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other