BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19341187 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02341
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    May 17, 2024
    Product Code
    FPA
    UDI-DI
    05705244018303
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-02341- DEVICE 3 OF 3

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 27-MAR-2024, IT WAS REPORTED THAT PATIENT FACED ADHESIVE ISSUE WITH THREE INFUSION SETS. INFUSION SET FELL OFF DURING USE. DURATION OF USE WAS 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 160-240 MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921619 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA 6000781 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown