BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23053952 · Received September 15, 2025

    Report

    Report Number
    3004464228-2025-42005
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 16, 2025
    Report Date
    September 15, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.2-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: G7 *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

    THE PATIENT'S LEGAL GUARDIAN (LG) REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 26.5 MMOL/L (477 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. PATIENT'S KETONE LEVELS WERE MEASURED TO BE 1.8 MMOL/L. LG REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE AND THE CANNULA WAS NOTED TO APPEAR BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760314 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K10212421 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male