BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21719742 · Received March 28, 2025

    Report

    Report Number
    3004464228-2025-13508
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    March 17, 2025
    Report Date
    March 28, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Adverse Event
    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. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. *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. CLOUD - LOCKED DOWN/SMARTPHONE LOCKDOWN CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.0.1 CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06 CLOUD - SMARTPHONE HARDWARE N5004L CLOUD - CGM SENSOR TYPE G6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE (LEG), WHILE WEARING THE DEVICE FOR LONGER THAN 48 HOURS. THE PATIENT REPORTS HAVING A LUMP AND A BRUISE AT THE POD INFUSION SITE. THE PATIENT WENT TO URGENT CARE. ONCE AT URGENT CARE THE PATIENT HAD AN ULTRASOUND ADMINISTERED. THE PATIENT WAS DIAGNOSED WITH AN ABSCESS AT THE POD INFUSION SITE. THE PATIENTS ABSCESS WAS LANCED AND DRAINED OF PURULENT DISCHARGE. THE PATIENT WAS AT URGENT CARE FOR 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580538 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male