BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 23462326 · Received November 4, 2025

    Report

    Report Number
    8021545-2025-02972
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2025-02972), WAS SUBMITTED ON 04-NOV-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 09-APR-2025. 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 6012759. IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH","LOT NUMBER" CRITERIA EQUAL 6012759. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6012759 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) [80] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 09-APR-2025 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED 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.

    Additional Manufacturer Narrative · 0

    PATIENT COUNTRY: CANADA. PATIENT CITY: (B)(6).

    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 CANADA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL WAS OVER 33 MMOL/L AT THE TIME OF EVENT. THE PATIENT WAS TREATED VIA INTRAVENOUS INSULIN AT THE HOSPITAL. THE KETONE LEVELS WERE HIGH. IT WAS REPORTED THAT THE PATIENT WAS CONFUSED, PUKING AND FEELING UNWELL AT THE TIME OF HOSPITALIZATION. THE PATIENT WAS IN THE HOSPITAL FOR ONE DAY. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERY SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2687059 INSET GUARD UNO EWIS BLUE 60/6 HCAP 5-PACK CA FPA UNOMEDICAL A/S MMT-431AG600 6012759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H