BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23422295 · Received October 30, 2025

    Report

    Report Number
    3003442380-2025-15489
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 22, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) DEVICE 4 OF 4. 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 6010718 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 20-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6010718. THE COUNT OF COMPLAINTS IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010718 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE L4 LI39 ON 11-DEC-2024, 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. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WI GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED. NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NC RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, 2 COMPLAINTS IN THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED. AS A RESULT OF THE POST MARKET SURVEILLANCE ACTIVITIES, THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 4 (ESCALATED TO CAPA): THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101 AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS RESULT OF TRENDING ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FOUR INFUSION SETS BENT CANNULA EVENT ON (B)(6) 2025 AND LATER, PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2025. THE INFUSION WAS USED THROUGHOUT THE NIGHT. THE INSERTION SITE WAS THIGH. THE PATIENT BLOOD GLUCOSE AT THE TIME OF EVENT WAS 568 MG/DL AND GOT TREATED WITH INTERAVENOUS AND FLUIDS OF SALINE AND INSULIN AND ZOFRAN IBUPROFEN. THE PATIENT WAS RELEASED ON (B)(6) 2025. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409328 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6010718 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention