BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19624950 · Received June 27, 2024

    Report

    Report Number
    3003442380-2024-10737
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 27, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    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 1895986 - MDR 3003442380-2024-10737 - DEVICE 2 OF 4. E1: PATIENT CITY: SAN JUAN. PATIENT COUNTRY: PUERTO RICO, U.S.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN PUERTO RICO, U.S. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET TAP NOT STICKING EVENT ON (B)(6) 2024. FELL OFF WAS NON-SERIALIZED PRODUCT BEING REPLACED. GETTING WET WAS CAUSE OF NON-ADHERING. ADHESIVE FAILING AFTER PATIENT WAS ENTERED IN POOL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722600 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A UNKNOWN 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown