BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21606376 · Received March 14, 2025

    Report

    Report Number
    3004464228-2025-11200
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 15, 2025
    Report Date
    March 14, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    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. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUSLY 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-PYROGEN CITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE. *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 3.1.1 CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06 CLOUD - SMARTPHONE HARDWARE N5004L CLOUD - CGM SENSOR TYPE G7.

    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 FEVER AS WELL AS SWELLING AND REDNESS AT THE POD INFUSION SITE. IN ADDITION THE PATIENT REPORTS HAVING DIFFICULTY MOVING THEIR LEG. THE PATIENT REPORTS THEY HAD GONE TO URGENT CARE. ONCE AT URGENT CARE THE PATIENT HAD BLOOD TESTS ADMINISTERED. THE PATIENT WAS DIAGNOSED WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENTS REPORTS HAVING A INCISION AT THE POD INFUSION SITE AND IT WAS DRAINED OF PURULENT DISCHARGE. THE PATIENT WAS PRESCRIBED 7 DAYS OF ANTIBIOTICS. THE PATIENT WENT BACK TO URGENT CARE AND RECEIVED ANOTHER ROUND OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415862 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U05082421 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female