BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19998128 · Received August 16, 2024

    Report

    Report Number
    3003442380-2024-21009
    Event Type
    Malfunction
    Date Received
    August 16, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER 1943407 EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS AT THE SITE. THE GLUCOSE LEVEL WAS 302 MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION BLOUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373142 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female