BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO ADVANCE

    MDR report key: 22209661 · Received June 16, 2025

    Report

    Report Number
    8021545-2025-01246
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 5, 2025
    Report Date
    January 22, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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). PATIENT COUNTRY: NETHERLANDS. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. 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: REVIEW OF COMPLAINT RECORD DATABASE 2222429 EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED AND NO LOT NUMBER SPECIFIC INFORMATION IDENTIFIED. REQUESTS FOR LOT SPECIFIC INFORMATION WERE SENT TO THE CUSTOMER BUT WERE UNABLE TO BE PROVIDED. AS A RESULT, AN INVESTIGATION WAS COMPLETED AT THE PRODUCT FAMILY LEVEL MIO ADVANCE AND MALFUNCTION TYPE (ADHESIVE ISSUE). SEE ATTACHMENT MIO ADVANCE ADHESION COMPLAINT CLOSURE INVESTIGATION FOR MORE INFORMATION. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION: DURING THE INVESTIGATION, TRENDING WAS IDENTIFIED TO BE ABOVE THE UPPER CONTROL LIMITS AS DESCRIBED IN ATTACHMENT MIO ADVANCE ADHESION COMPLAINT CLOSURE INVESTIGATION. CAPA-2010953 WAS OPENED 18-SEP-2024 FOR ADHESIVE RELATED COMPLAINT AND BOUNDING COVERS MIO ADVANCE PRODUCTS AND THE TIME PERIOD REVIEW. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE CONCLUDED THAT THERE IS NO EVIDENCE OF A SYSTEMIC ADHESIVE ISSUE EXTENDING TO THE 3-DAY ADHESIVE, HOWEVER THERE IS ALSO A LACK OF DESIGN VERIFICATION PEEL-TEST DATA FOR THESE DEVICES ALONG WITH THE SAME VALIDATED TEST METHODS TO QUANTIFY ADHESION PERFORMANCE. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: DATABASE-2507117 OPENED TO REVIEW DESIGN INPUTS FOR 3-DAY ADHESIVES. DATABASE-2507115 OPENED TO COMPLETE ASSOCIATED METHOD VALIDATION AND VERIFICATION TESTING. SUMMARY CONCLUSION: BASED ON THE LACK OF LOT SPECIFIC INFORMATION, NO PRODUCTS RETURNED TO TEST, AND CAPA-2010953 INVESTIGATION CONCLUSION, THE COMPLAINT WILL BE CLOSED AS COMPLAINT UNCONFIRMED AS ANALYSED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS. IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND INFUSION SET LOOSE EVENT. BLOOD GLUCOSE LEVEL WAS ABOVE 33 MMOL/L AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS FOR ONE DAY AND NIGHT. PATIENT WAS TREATED WITH INSULIN THROUGH PEN. PATIENT WAS EXPERIENCED THE SYMPTOMS OF FEELING, SICK AND CONFUSION. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. KETONES LEVEL WAS 6.1 MG/DL. 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
    1594075 MINIMED MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-242A UNKNOWN 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R