BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25313797 · Received May 28, 2026

    Report

    Report Number
    3014585508-2026-31144
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    June 21, 2025
    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 DEVELOPED AN INFECTION AT THE INFUSION SITE (LOWER BACK) WHILE WEARING THE POD. THE PATIENT REMOVED THE POD ON (B)(6) 2025 AS THEY WERE EXPERIENCING PAIN WHILE WEARING THE PUMP AND UP REMOVAL THEY NOTICED PURULENT DISCHARGE AT THE INFUSION SITE. ON (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE A HIGH FEVER AND THE SITE STILL PAINFUL WITH PURULENT DISCHARGE AND NOW WARM TO THE TOUCH SO THE PATIENT SOUGHT MEDICAL ATTENTION AT AN URGENT CARE CENTRE. THE PATIENT WAS CONFIRMED TO HAVE AN ABSCESS, THIS WAS DRAINED AND THE PATIENT WAS PRESCRIBED CO-AMOXICLAV AS TREATMENT AND WAS ADVISED TO PRESENT AT THE HOSPITAL IF THE INFECTION DID NOT IMPROVE. ON EITHER (B)(6) 2025 OR (B)(6) 2025 (PATIENT CANNOT RECALL EXACT DATE), THE PATIENT WAS THEN HOSPITALISED AT (B)(6). THE ABSCESS WAS SURGICALLY REMOVED AND THE PATIENT RECEIVED FURTHER UNSPECIFIED ANTIBIOTICS AS TREATMENT. THE WOUND WAS PACKED AND THE PATIENT HAD REGULAR FOLLOW UPS TO REPACK AND DRESS THE WOUND UNTIL (B)(6) (EXACT DATE NOT PROVIDED). THE PATIENT DISCARDED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296503 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