BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5

    MDR report key: 17756263 · Received September 14, 2023

    Report

    Report Number
    MW5145683
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 12, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECENTLY SWITCHED TO THE OMNIPOD SYSTEM. AND IT HAS BEEN TERRIBLE MULTIPLE LOW EVENTS, POD ERRORS, UNCONTROLLABLE HIGHS AND LOWS. HEAD AND MUSCLE PAINS FROM THE HUGE VARIATIONS IN BLOOD SUGAR. POOR COMMUNICATION FROM THE COMPANY. ALSO AFTER GETTING CLOSE TO DYING MULTIPLE TIMES (SAW VISIONS WHILE OUT AND EVERYTHING. THAT'S WHAT I DETERMINED TO BE CLOSE TO DYING) I STARTED REACHING OUT TO THE COMPANY WITH COMPLAINTS. I TALKED TO SOME CORPORATE PEOPLE BUT THE ISSUE WAS NOBODY WAS ABLE TO FIX IT SO I KEPT TRYING TO FIND SOMEBODY ELSE WITHIN THE COMPANY CAUSE I DON'T WANT TO DIE. THEY HAVE BLOCKED ME FROM THEIR INSTAGRAM, THEIR 800 NUMBER AND TRYING TO EMAIL NO RESPONSES. NOW THEY ARE FORWARDING EVERYTHING TO MY DOCTOR AND NOW SHE WANTS TO QUIT ON ME BECAUSE OF MY RESPONSES TO THEM. WHEN ONLY TRYING TO FIGURE OUT WHY I KEEP HAVING HUGE VARIATIONS IN BLOOD SUGARS 400 HIGHS AND 40 LOWS AND CANNOT STOP OR CHANGE IT. I HAVE BEEN SUSPENDED AND THE POD KEPT PUMPING. THAT ONE WAS PRETTY SCARY. SO MANY ISSUES I WOULD HAVE TO GO THROUGH THE EMAILS TO SHOW Y¿ALL. LAB TESTS ARE AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295128 OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION 5

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Hospitalization| O| R