BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25089617 · Received May 5, 2026

    Report

    Report Number
    3014585508-2026-25953
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 5, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE ABSCESS. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 BY THE LEGAL GUARDIAN (LG) THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INFUSION SITE (LEG) WHILE WEARING THE POD BETWEEN 49 AND 71 HOURS. THE INFUSION SITE WAS REPORTED TO HAVE PAIN DUE TO INFLAMMATION AND PURULENT DISCHARGE. THE PATIENT WENT TO A PREVENTIVE CHECK-UP WITH THEIR DIABETOLOGIST AT MVZ ALTONA KINDERKRANKENHAUS AND WAS DIAGNOSED WITH ABSCESS. THE PATIENT WAS TREATED WITH THE HEALTHCARE PROFESSIONAL DISINFECTING AND MANUALLY DRAINING THE ABSCESS, AND APPLYING ADHESIVE OVERLAY. A NEW POD WAS APPLIED AT A DIFFERENT INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598779 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K06222531 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female