BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19475938 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06592
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 5, 2024
    Report Date
    June 6, 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 1880327- MDR 3003442380-2024-06592- DEVICE 2 OF 3 E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT THREE INFUSION SET WAS LEAKING FROM ITS SITE WITHIN 2 DAYS OF USE. NO FURTHER INFORMATION WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688497 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6004662 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| D