BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 24750861 · Received April 1, 2026

    Report

    Report Number
    3003442380-2026-06273
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 4, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: CITTÀ. PATIENT COUNTRY: ITALY.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2026 AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO A BENT CANNULA LEADING TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT. THE PATIENT WAS TREATED WITH CORRECTION BOLUSES VIA PUMP AND INJECTIONS, REQUIRING IV INSULIN INFUSION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE LENGTH OF EMERGENCY ROOM STAY WAS FOR FOUR DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812509 INSET II INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL UM-D 1002817 6008544 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H