BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19329494 · Received May 16, 2024

    Report

    Report Number
    3003442380-2024-02183
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Report Date
    December 18, 2025
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 5 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT FOR THE 7 INFUSION SET LEAKAGE ON THE FIRST DAY OF USE DUE TO WHICH HYPERGLYCEMIA AND MODERATE KETONES OCCURRED. PATIENT ALSO NOTICED SCAR TISSUE. EVENT OCCURRED IN 03/27/2024, 03/28/2024, 03/29/2024, 03/30/2024, 03/31/2024, 04/01/2024 AND 04/02/2024.INFUSIONN SET WAS PLACED IN THE ABDOMEN. HIGH BLOOD GLUCOSE IS CORRECTED BY INJECTION VIA MDI. NO FURTHER INFORMATION WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546825 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA 6001759 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown