BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23410739 · Received October 29, 2025

    Report

    Report Number
    3003442380-2025-15429
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 6011560, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 28-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011560". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. TEST RESULTS: NO SAMPLE WILL BE RETURNED, AS STATED IN THE REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011560 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 76 AND MANUFACTURED IN INSET 5 ON 03-MAR-2025 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. ONE NON-CONFORMANCE (NC) WAS IDENTIFIED, DELAMINATED ADHESIVE TAPE, THIS MALFUNCTION ITS NOT RELATED TO THE COMPLAINT, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 FRANCE. IT WAS REPORTED THAT THE PATIENT INSERTED THE BENT CATHETER ON (B)(6) 2025. THE PATIENT EXPERIENCED HYPERGLYCEMIA ALL NIGHT, AND THE BENT CATHETER WAS REPLACED THE NEXT DAY. THE BLOOD GLUCOSE LEVEL WAS OVER 350 MG/DL AND ACETONE AT 1.8, AS WELL AS NAUSEA AND VOMITING. THE PATIENT TREATED WITH A BOLUS WITH A PEN AND WAS TAKEN TO THE EMERGENCY ROOM. 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
    211188 INSET II UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-060-52B6 6011560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown