BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 APP

    MDR report key: 23244031 · Received October 8, 2025

    Report

    Report Number
    3004464228-2025-46716
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICAL CONTROLLER WAS NOT RECEIVED FOR INVESTIGATION. IOS LOG FILES FROM THE COMPLAINT DEVICE WERE UPLOADED TO THE CLOUD SYSTEM BY THE USER AND DOWNLOADED FOR INVESTIGATION. REVIEW OF THE IOS LOG FILES FOUND NO EVIDENCE OF UNEXPECTED BOLUS AMOUNT CHANGES. THE LOGS SHOWED THAT A 4.5 U BOLUS WAS DELIVERED ON THE DATE OF OCCURRENCE AS REPORTED. THE LOGS SHOWED THAT 25 G OF CARBS WERE ENTERED INTO THE BOLUS CALCULATOR, RESULTING IN A BOLUS CALCULATION OF 3.1 U. THE LOGS THEN SHOW THAT THE TOTAL BOLUS BOX WAS TAPPED INTO AND THE AMOUNT WAS MANUALLY ADJUSTED ONE DIGIT AT A TIME TO 47, WHICH IS LARGER THAN THE USER'S MAX BOLUS SETTING AND SO THE APP CORRECTLY GENERATED MESSAGES SAYING THAT THE MAX BOLUS WAS EXCEEDED. THE TOTAL BOLUS BOX WAS TAPPED INTO AGAIN AND THE TOTAL WAS MANUALLY ADJUSTED ONE DIGIT AT A TIME TO 4.5. THE LOGS THEN SHOW THE CONFIRM BUTTON BEING PRESSED TO BEGIN DELIVERY OF THE 4.5 U BOLUS. THE LOGS SHOW EVIDENCE OF INTERACTION WITH THE CONTROLLER TO INCREASE THE BOLUS AMOUNT FROM THE ONE CALCULATED. NO EVIDENCE OF AN UNEXPECTED BOLUS CALCULATION WAS OBSERVED IN THE AVAILABLE LOGS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS OMNIPOD SOFTWARE APP VERSION: 2.0.2 OPERATING SYSTEM: 17.6 HARDWARE: IPHONE16.1 CGM SENSOR TYPE: G6 PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED ON SEVERAL OCCASIONS THE PATIENT'S OMNIPOD 5 APP CHANGED THE AMOUNT OF A PROGRAMMED BOLUS AND DELIVERED A HIGHER AMOUNT THAT RESULTED IN BLOOD GLUCOSE LEVEL DECLINING TO 50 MG/DL. PATIENT DENIED OVERRIDING BOLUS AMOUNT SUGGESTED. INFORMATION ON HOW THE HYPOGLYCEMIA WAS TREATED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521323 OMNIPOD 5 APP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-002343

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female