BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 23604522 · Received November 20, 2025

    Report

    Report Number
    3004464228-2025-57617
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 20, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6 PER ISO11135 AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE. OCKED DOWN SMARTPHONE: LOCKDOWN. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. 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

    THE PATIENT REPORTED THAT THEY REMOVED THE POD FROM THEIR ABDOMEN AND NOTICED THAT THERE WERE REDNESS AND IRRITATION. THE PATIENT STATED THEY WENT TO URGENT CARE ON AN UNSPECIFIED DATE TO SEEK MEDICAL ATTENTION. THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND TREATED WITH ANTIBIOTICS. THE SPECIFIC MEDICATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262929 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female