BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO ADVANCE

    MDR report key: 21916249 · Received April 28, 2025

    Report

    Report Number
    8021545-2025-00837
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    March 23, 2025
    Report Date
    September 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018938
    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). PATIENT COUNTRY: UNITED STATES.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND 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 6002152 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6002152". 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 6002152 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) [79] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 7-AUG-2023, 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 STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO HOSPITAL FOR MORE THAN 24 HOURS ON (B)(6) 2025 AND RECEIVED INTRAVENOUS (IV) FLUIDS WITH INSULIN SALINE AND THE PATIENT BLOOD GLUCOSE LEVELS WHILE ADMITTING THE HOSPITAL WAS UNKNOWN. THE PATIENT HAD SYMPTOMS SUCH AS SEIZURE AND THE MAIN REASON FOR HOSPITALIZATION WAS LOW BLOOD GLUCOSE LEVELS. NO FURTHER INFORMATION WAS 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
    1429362 MINIMED MIO ADVANCE UNO MIO ADV. GREY 110/9 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-244A 6002152 05705244018938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R