BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO ADVANCE

    MDR report key: 23070568 · Received September 17, 2025

    Report

    Report Number
    8021545-2025-02420
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    November 18, 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

    E1: PATIENT CITY: (B)(6).

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2025-02420), WAS SUBMITTED ON 17-SEP-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 11-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 6012736 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 18-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6012736". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3 SO NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012736 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) [80] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 11-APR-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 SAMPLE WAS PROVIDED. 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, 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 THE UNITED ARAB EMIRATES. THE PATIENT REPORTED HIGH BLOOD GLUCOSE READINGS, THOUGH THEY WERE UNCERTAIN ABOUT WHAT LED TO THIS EVENT. THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR IN THE FORM OF MANUAL INSULIN INJECTIONS. THE HIGH BLOOD GLUCOSE EVENT RESULTED IN AN EMERGENCY ROOM VISIT ON (B)(6) 2025. UPON ADMISSION, THE PATIENT HAD A BLOOD GLUCOSE VALUE OF 390 MG/DL. THE HOSPITAL VISIT LASTED LESS THAN 24 HOURS. THE PATIENT REPORTED FEELING SICK/UNWELL PRIOR TO THE HOSPITAL VISIT AND TESTED POSITIVE FOR KETONES (+2). DURING THE HOSPITAL STAY, INSULIN WAS ADMINISTERED VIA MANUAL INJECTION. THE REASON FOR THE VISIT WAS DOCUMENTED AS "HIGH BLOOD GLUCOSE LEVELS." 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
    1731979 MINIMED MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6012736 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown