BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 16450731 · Received February 28, 2023

    Report

    Report Number
    3003442380-2023-00189
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Report Date
    February 28, 2023
    Product Code
    FPA
    UDI-DI
    05705244014541
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING WAS DETACHED FROM CONNECTOR ON (B)(6)2023 AND (B)(6) 2023. THE ISSUE OCCURRED WITH 2 SIMILAR TYPE OF INFUSION SETS USED FOR 5-6 HOURS FOR BOTH THE EVENTS. THE PATIENT'S BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 113-125 MG/DL AT THE TIME OF THE EVENT. FURTHER, THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856273 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA 1000281 UNKNOWN 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown