BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO ADVANCE

    MDR report key: 22746966 · Received August 8, 2025

    Report

    Report Number
    8021545-2025-02082
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 31, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER H4. 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 6012345 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 31-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH","LOT NUMBER" CRITERIA EQUAL 6012345. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6012345 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) [80] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 26-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. 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

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: THE UNITED STATES.

    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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN PUMP AND INTRAVENOUS DRIP. THE LENGTH OF HOSPITALIZATION WAS FOR GREATER THAN 24 HOURS. THE PATIENT ALSO HAD SYMPTOMS LIKE VOMITING AND HEADACHE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589661 MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6012345 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R