BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25314052 · Received May 28, 2026

    Report

    Report Number
    3014585508-2026-31147
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 21, 2026
    Report Date
    May 28, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    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 AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.6 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: DATA NOT AVAILABLE 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 SOUGHT MEDICAL ATTENTION IN EARLY SEPTEMBER 2025 (PATIENT UNABLE TO RECALL EXACT DATE) WITH AN INFECTION THAT DEVELOPED AT THE INFUSION SITE (LEG) WHILE WEARING THE POD. THE PATIENT WAS ATTENDING AN APPOINTMENT WITH THEIR GENERAL PRACTITIONER TO REPACK THEIR SURGICAL WOUND FROM A PREVIOUS INFECTION (SEE RELATED CASE (B)(4) ) AND ASKED THE DOCTOR TO ALSO LOOK AT THE SITE FROM A RECENTLY REMOVED POD. THE SITE WAS REPORTED TO HAVE BLED WHEN THE POD WAS REMOVED AND THEN BECAME BRUISED AND PAINFUL. THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED CO-AMOXICLAV AS TREATMENT. THE POD HAS BEEN DISCARDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584439 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