BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19736514 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-13926
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 11, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911059 -DEVICE 2 OF 2. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833655 MINMED QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6003854 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown