BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19830614 · Received July 25, 2024

    Report

    Report Number
    8021545-2024-02536
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 23, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1920959 - MDR 8021545-2024-02536- DEVICE 4 OF 10 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. ON 24-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED THAT WHOLE BOX OF INFUSION SETS HAD BEEN LEAKING FROM QUICK RELEASE, WHICH CAUSE THE PATIENT BLOOD GLUCOSE ELEVATED TO 263 MG/DL. THE INFUSION SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207555 MIO¿ ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6004304 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown