BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19728515 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13663
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 8, 2024
    Report Date
    July 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    00570524418051
    PMA / PMN Number
    K160648
    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: NETHERLANDS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS. IT WAS REPORTED THAT THE PATIENT VISITED ER AND EVENTUALLY HOSPITALISED DUE TO HIGH BLOOD GLUCOSE LEVEL ON (B)(6) 2024.THE INSULIN SET WAS IN USE FOR 48 HOURS. THE BLOOD GLUCOSE LEVEL WAS 28 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426718 QUICK SET PARADIGM UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL A/S MMT-396A 6004815 00570524418051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization