BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19736737 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-14365
    Event Type
    Injury
    Date Received
    July 13, 2024
    Date of Event
    June 4, 2024
    Report Date
    September 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911195 - MDR 3003442380-2024-14365 - DEVICE 3 OF 3 E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: (B)(6)

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) ON (B)(6)2024, IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENT AND GOT HOSPITALIZED. INSERTION SITE WAS AT ABDOMEN. THE SET WASIN USE FOR ONE DAY AND PATIENT NOTICED BENT CANNULA AFTER ONE DAY OF USE. BLOOD GLUCOSE LEVELS WERE 460 MG/DL AT THE TIME OF EVENT AND KETONES LEVELS WERE 0.3 (NO UNITS AVAILABLE). PATIENT TOOK PEN INJECTION TO TREAT HIGH BLOOD GLUCOSE LEVELS. PATIENT GOT HOSPITALIZED FOR 2 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862366 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 5372772 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention