BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19679013 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-12252
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    March 23, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1904638 - MDR 3003442380-2024-12252 - DEVICE 2 OF 4

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) ON (B)(6)2024 AND (B)(6)2024, IT WAS REPORTED THAT PATIENT FACED 2 EVENTS OF INFUSION SET FELL OFF DURING USE. THE EVENTS OCCURRED WITHIN 24 TO 48 HOURS OF INSERTION. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472977 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6003399 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male