BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 24751548 · Received April 1, 2026

    Report

    Report Number
    3003442380-2026-06471
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 3, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFRENCE NUMBER (B)(4). EVENT OCCURED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE LEVEL AND MILD DIABETIC KETOACIDOSIS ON (B)(6) 2026, AS THE CUSTOMER STATED THAT HE USED OFF LEBELLED INSULIN WITH INFUSION SET. THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MDI (MULTIPLE DAILY INJECTIONS). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814914 INSET II UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002819 6016407 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention