BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET, INSET II, T:90

    MDR report key: 19947629 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-20203
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    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 1935379 - MDR 3003442380-2024-20203 - DEVICE 1 OF 2 H11: 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 WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SETS KINKED CANNULA WITHIN 3 OR MORE HOURS OF INSERTION. SITE OF INSERTION WAS AT ABDOMEN. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 398 OR 399 MG/DL. INFUSION SETS WERE IN USE FOR LESS THAN 24 HOURS FOR MOST OF THE EVENTS AND MORE THAN 24 HOURS BUT LESS THAN 48 HOURS FOR ONE EVENT. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646614 INSET, INSET II, T:90 UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 UNKNOWN 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female