BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19294786 · Received May 11, 2024

    Report

    Report Number
    8021545-2024-00266
    Event Type
    Malfunction
    Date Received
    May 11, 2024
    Report Date
    May 7, 2024
    Product Code
    FPA
    UDI-DI
    05705244022928
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1860269 - MDR 8021545-2024-00266 - DEVICE 2 OF 2.

    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 INFUSION SET NOT ADHERING. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742959 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 1-PK INT FPA 6004553 05705244022928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown