BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

     AUTOSOFT 90

    MDR report key: 19842242 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16806
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 22, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1922583- MDR 3003442380-2024-16806- DEVICE 2 OF 15. E1: PATIENT COUNTRY : UNITED KINGDOM.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED FIFTEEN INFUSION SETS FELL OFF EVENTS DURING DOING USE ON DATE 22-JUNE-2024. THE INFUSION SET WAS IN USE FOR 1 DAY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598686  AUTOSOFT 90  INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S  INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown