BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN - IDD

    MDR report key: 20094595 · Received August 29, 2024

    Report

    Report Number
    3003442380-2024-23075
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    June 22, 2024
    Report Date
    July 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1970951 - MDR 3003442380-2024-23075 - DEVICE 8 OF 8 H1: 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 WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE IT WAS REPORTED THAT PATIENT FACED 8 INFUSION SET CANNULA DETACHMENTS WITH 2 INSULIN LEAKS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990384 INFUSION DEVICES - UNKNOWN - IDD INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN IDD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown