BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19847485 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17150
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    April 27, 2024
    Report Date
    July 28, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1923573 - MDR 3003442380-2024-17150 - DEVICE 5 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SETS FELL OFF EVENTS DURING USE ON DATE (B)(6) 2024. THE INFUSION SETS WERE IN USE FOR FEW HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922268 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S UNKNOWN 6003148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male