BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24939140 · Received April 21, 2026

    Report

    Report Number
    3003442380-2026-08776
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244018334
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 2 OF 3. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FACED THREE INFUSION SETS TUBING DETACHMENT EVENTS FROM CONNECTOR ON 01-MAR-2026, 16-MAR-2026, AND 19-MAR-2026. THE INFUSION SETS WERE USED FOR LESS THAN TWELVE HOURS. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215124 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1002824 6016983 05705244018334

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male