BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23048365 · Received September 15, 2025

    Report

    Report Number
    3003442380-2025-13703
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 31, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: ON AUGUST 19TH, 2025, DURING THE INVESTIGATION OF COMPLAINT (B)(4) RELATED TO OCCLUSION, REFERENCE SAMPLES FROM LOT 6010640 OF PRODUCT INSET II, PART NUMBER 86-046-52B6, WERE SUBJECTED TO VISUAL INSPECTION AND FLOW TESTING AND ADDITIONAL LEAK TESTING. LEAKAGE WAS OBSERVED IN SAMPLES 1, TO 6 AT THE CANNULA COMPONENT, SPECIFICALLY AT THE UPPER MEMBRANE AREA. THIS ISSUE WAS IDENTIFIED DURING A LEAK TEST CONDUCTED UNDER WATER FOR 30 SECONDS. NO HARM OR CLINICAL CONSEQUENCES WERE REPORTED FOR ANY PATIENT, AS THIS FAILURE WAS DISCOVERED DURING AN INTERNAL INVESTIGATION OF A SEPARATE COMPLAINT. THE ISSUE WAS FOUND IN REFERENCE SAMPLES AS PART OF TESTING AND WAS NOT PRESENT IN DISTRIBUTED PRODUCT.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET INSULIN LEAKAGE FROM THE SUPERIOR MEMBRANE ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469127 INSET II UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-046-52B6 6010640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown