BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19294781 · Received May 11, 2024

    Report

    Report Number
    8021545-2024-00236
    Event Type
    Malfunction
    Date Received
    May 11, 2024
    Report Date
    May 7, 2024
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1860166 - MDR 8021545-2024-00236 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 11 APRIL 2024, IT WAS REPORTED THAT ONE INFUSION SET FELL OFF DURING USE. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742954 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 10PK INT FPA 6003102 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown