BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23081624 · Received September 18, 2025

    Report

    Report Number
    3004464228-2025-42593
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 18, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Adverse Event
    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. 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 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. 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: 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

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE (RIGHT LEG) WHILE WEARING THE DEVICE FOR BETWEEN 37 AND 48 HOURS. THE PATIENT¿S INFUSION SITE HAD UNSPECIFIED DRAINAGE, BLEEDING, REDNESS, INFLAMMATION, AND HARDNESS. ADDITIONALLY, THE PATIENT EXPERIENCED BLOOD GLUCOSE OF 22 MMOL/L (396 MG/DL), A HEADACHE, AND FEELING UNWELL. THE PATIENT SOUGHT MEDICAL ATTENTION AT BIRCHGROVE SURGERY GENERAL PRACTICE- CAERPHILLY RD, CARDIFF CF14 4QJ, UK (PROVIDER¿S NAME WAS UNSPECIFIED) AND WAS DIAGNOSED WITH AN INFECTION. THE PATIENT WAS TREATED WITH A PRESCRIPTION FOR AN UNSPECIFIED ANTISEPTIC CREAM. THE POD HAD BEEN REMOVED PRIOR TO SEEKING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640240 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K12062431 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female