BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19847458 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17072
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    June 1, 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 1923531 - MDR 3003442380-2024-17072 - DEVICE 2 OF 4

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS FELL OFF EVENTS WHILE DURING PHYSICAL ACTIVITY ON DATE 01-JUNE-2024, 03-JUNE-2024 AND 06-JUNE-2024. THE INFUSION SET WAS IN USE FOR LESS THAN 1 DAY. BLOOD GLUCOSE LEVEL DURING FIRST EVENT WAS 150 MG/DL, FOR SECOND EVENT 250MG/DL, FOR THIRD EVENT 150 MG/DL AND FOR FOURTH EVENT IT WAS 100 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922241 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6004412

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male