BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 21571842 · Received March 11, 2025

    Report

    Report Number
    3004464228-2025-10424
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 11, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. CLOUD - LOCKED DOWN/SMARTPHONE DATA NOT AVAILABLE CLOUD - OMNIPOD 5 SOFTWARE APP VERSION DATA NOT AVAILABLE CLOUD - SMARTPHONE OPERATING SYSTEM DATA NOT AVAILABLE CLOUD - SMARTPHONE HARDWARE DATA NOT AVAILABLE CLOUD - CGM SENSOR TYPE DATA NOT AVAILABLE *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE OVER 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (KEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, 4 UNITS OF BOLUS WAS ADMINISTERED AND A NEW POD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309587 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male