BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23508410 · Received November 10, 2025

    Report

    Report Number
    3003442380-2025-15926
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 20, 2025
    Report Date
    January 8, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    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 (B)(4). - DEVICE 5 OF 8

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) MDR 3003442380-2025-15926. 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 07-JAN-2026 AGAINST "LOT NUMBER 6011405 AND SIMILAR MALFUNCTION CODE(S): LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICIAL WETNESS. LEAKAGE AT INFUSION SITE - SIGNIFICANT WETNESS / POOLING. THE REVIEW CONFIRMED THAT LOT 6011405 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 07-JAN-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011405 AND SIMILAR MALFUNCTION CODES LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICIAL WETNESS. LEAKAGE AT INFUSION SITE - SIGNIFICANT WETNESS / POOLING. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009683 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE # 04 ON 29/JAN/2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT # 4K05985 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 2.0 AND MANUFACTURED IN THE MACHINE ITL03, ON 06/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT # 4M02672 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC03, ON 12/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT # 4M00916 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC03, ON 04/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI-001031 (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6011405 AND RELATED MALFUNCTION CODES FOR LEAK. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. FOR MORE DETAILS SEE THE INFORMATION UNDER THE CHILD INV RECORD (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT EXPERIENCED EIGHT INFUSION SET LEAKAGES FROM THE TOP OF THE INFUSION SET ON (B)(6) 2025, RECURRING EVERY 2 DAYS, WITH ADDITIONAL LEAKAGE FROM THE CANNULA OCCURRING AFTER 1-1.5 DAYS. THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL EXCEEDED 500 MG/DL AND WAS TREATED WITH A CORRECTION BOLUS VIA PUMP. AFTER WAITING AN HOUR, THE PATIENT ADMINISTERED A CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    171869 INSET UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 6011405 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male