BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25111398 · Received May 7, 2026

    Report

    Report Number
    3014585508-2026-26316
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 7, 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 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. LOCKED DOWN SMARTPHONE: DATA NOT AVAILABLE OMNIPOD SOFTWARE APP VERSION: DATA NOT AVAILABLE OPERATING SYSTEM: DATA NOT AVAILABLE HARDWARE: DATA NOT AVAILABLE 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

    A USER REPORT HAS BEEN RECEIVED FROM MHRA (REFERENCE NUMBER: 2026/004/027/501/006); IT HAS BEEN REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PATIENT HAS EXPERIENCED TWO POD SITE INFECTIONS REQUIRING ANTIBIOTICS BETWEEN THE DATES OF (B)(6) 2026 (NAME AND DOSE OF ANTIBIOTIC NOT SPECIFIED). THE PATIENT REPORTEDLY SHOWERS AND ALLOWS THE POD SITE TO DRY PRIOR TO A POD CHANGE. THE PATIENT SOUGHT MEDICAL ATTENTION AT AN OUT OF HOURS URGENT CARE CENTRE AND REPORTEDLY FELT UNWELL AFTER STARTING THE ANTIBIOTIC COURSE. NO FURTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A SECOND CASE HAS BEEN REPORTED UNDER INSULET REFERENCE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112277 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 50 YR Female Required Intervention