BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20148562 · Received September 5, 2024

    Report

    Report Number
    3003442380-2024-24366
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014541
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1962288 - MDR 3003442380-2024-24366 - DEVICE 1 OF 5. 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 WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 28-JUL-2024 AND 29-JUL-2024, IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS KINKED CANNULAS WITHIN 3 HOURS OF INSERTION. SITE OF INFUSION SETS WERE ABDOMEN, UPPER BUTTOCKS AND HIP. PATIENT'S BLOOD GLUCOSE AT THE TIME OF ISSUE WAS REPORTED AS HIGH. PATIENT TOOK CORRECTION INJECTION VIA MDI TO ADDRESS HIGH BG. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035538 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1000281 UNKNOWN 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female