BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19728593 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13635
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1910278 - MDR 3003442380-2024-13635 - DEVICE 2 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS FELL OFF DURING USE IN WHICH TWO EVENTS ON (B)(6) 2024 AND THREE EVENTS ON (B)(6) 2024. INFUSION SET HAS BEEN USED FOR A FEW HOURS. THE PATIENT RESOLVED THE EVENT BY REPLACING THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272227 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6002938 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown