BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 13495770 · Received February 9, 2022

    Report

    Report Number
    3003442380-2022-00276
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Report Date
    February 9, 2022
    Product Code
    FPA
    UDI-DI
    05705244018334
    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. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT'S INFUSION SET'S TUBING DETACHED/BROKEN AT THE SITE CONNECTOR PRIOR TO INSERTION AND THIS ISSUE OCCURRED WITH THREE INFUSIONS SETS. THEREFORE, HIS BLOOD GLUCOSE LEVEL WAS 225 MG/DL AT THE TIME OF THE EVENT. MOREOVER, THEY REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT'S INFUSION SET'S TUBING DETACHED/BROKEN AT THE SITE CONNECTOR PRIOR TO INSERTION AND THIS ISSUE OCCURRED WITH THREE INFUSIONS SETS. THEREFORE, HIS BLOOD GLUCOSE LEVEL WAS 225 MG/DL AT THE TIME OF THE EVENT. MOREOVER, THEY REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375899 AUTOSOFT 90 UNO INSET II 60/9 BLUE TCAP 10PK INT FPA 1002824 UNKNOWN 05705244018334

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown