BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 20329615 · Received September 29, 2024

    Report

    Report Number
    3003442380-2024-25177
    Event Type
    Malfunction
    Date Received
    September 29, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 8, 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 2001013 - MDR 3003442380- 2024 - 25177 - DEVICE 2 OF 2 E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES H11 : SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT EXPERIENCED SHE IS CURRENTLY IN THE HOSPITAL AND TOOK TWO OF HER INFUSION SETS WITH HER AND PATIENT NOTED THAT 2 INFUSION SET TUBING WERE KINKED AND PATIENT TRIED TO USE SET LAST NIGHT BUT IT WAS WASTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603255 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