BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5

    MDR report key: 24664275 · Received March 23, 2026

    Report

    Report Number
    MW5185599
    Event Type
    Injury
    Date Received
    March 23, 2026
    Report Date
    March 15, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SWITCHED FROM FINGER PRICK TO DEXCOM G7 PAID WITH OMNIPOD 5. SINCE THE SWITCH, I¿VE HAD UNSTABLE BLOOD SUGAR WITH HIGHS 500+ TO LOWS 36. I¿VE NEVER HAD THESE LARGE OF SWINGS DAILY AND FOR MANY MONTHS STRAIGHT. SWITCHED ENTIRE DOCTORS AND MEDICAL FACILITIES AND STILL HAVING ISSUES. I¿VE BEEN TOLD BY MEDICAL PROFESSIONALS THAT IT WAS GOING TO GET BETTER AS THEY ADJUST I AND TO NOT WORRY AS THERE'S SAFETY BUILT IN TO NOT ALLOW ME TO CRASH OR SPIKE. THIS IS NOT TOTALLY TRUTHFUL. THIS NEW SYSTEM HAS ME SCARED FIGHTING FOR MY LIFE EATING STRAIGHT SUGAR TO KEEP BLOOD SUGAR ABOVE 70. THIS WEEK I HAVE A DOCTOR'S APPOINTMENT AND AM BRINGING A FRIEND WITH TO HELP ADVOCATE WITH ME. I¿M A GROWN ADULT AND KNOW THIS SYSTEM NEEDS TO BE OUTLAWED OR PEOPLE WILL START DYING AND ER HOSPITALS WILL BE OVERWHELMED WITH PEOPLE ON THIS. PATIENT CODE: 1912;1905. DEVICE CODE: 1535. REFERENCE REPORT: MW5185598.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732602 OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention