BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19738709 · Received July 15, 2024

    Report

    Report Number
    3003442380-2024-14543
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 15, 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 1913423 - MDR 3003442380-2024-14543 - DEVICE 3 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. IT WAS REPORTED THAT PATIENT FACED 3 INFUSIONS SET LEAKAGE AT SITE EVENT ON (B)(6)2024. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499390 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A UNKNOWN 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown