BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET

    MDR report key: 20889946 · Received December 10, 2024

    Report

    Report Number
    3003442380-2024-34013
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 8, 2024
    Report Date
    September 4, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K070430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 DUE TO INSULIN FLOW BLOCKED ALARM. BLOOD GLUCOSE LEVEL WAS 20 MMOL/L AT THE ITME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS (IV) DRIP. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526977 QUICK-SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL A/S MMT-398A 5350725 05705244017931

    Patients

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