BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23402732 · Received October 28, 2025

    Report

    Report Number
    3003442380-2025-15384
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 18, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    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 - COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010635, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. TEST RESULTS: THE REFERENCE SAMPLES FOR THE LOT 6010635 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 25-JUL-2025. NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO (WI) VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST UNDER WATER LEAK ACCORDING (WI) VERSION 2 ON REFERENCE SAMPLES, 4 SAMPLE OF 10 SAMPLES WAS FOUND LEAKING BY UPPER MEMBRANE. LEAKAGE (NOT CONFIRMED TO BE SET RELATED) (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). THRESHOLD ANALYSIS: A QUERY WAS RUN ON 17-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6010635". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010635 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 75 AND PACKAGING IN THE LINE 06, ON 02/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCAEMIA AND DIABETIC KETOACIDOSIS (DKA). THE BLOOD GLUCOSE LEVEL WAS 533MG/DL AT 3:00 A.M. THEN THE CATHETER WAS CHANGED. AT 5:00 A.M., THE CATHETER AND INSULIN VIAL WERE CHANGED AGAIN BECAUSE THE PATCH WAS SOAKED WITH INSULIN DUE TO WHICH THE INSULIN DROPPED. AT HOSPITAL THE GLUCOSE LEVEL WAS 335 MG/DL AND IT CONTINUED TO DROP. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) FLUIDS AND ORAL FLUID INTAKE. THE LENGTH OF HOSPITALIZATION WAS LESS THAN 24 HOURS. THE PATIENT ALSO TESTED POSITIVE FOR KETONES (KETONES WERE DECTED IN THE URINE). NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259643 INSET II UNO INSET II 80/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. UL3161 6010635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention