BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED MIO ADVANCE

    MDR report key: 21948334 · Received May 2, 2025

    Report

    Report Number
    8021545-2025-00893
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    March 29, 2025
    Report Date
    January 24, 2026
    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). PATIENT COUNTRY: SPAIN. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. 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 (B)(4) EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6010934 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS. NO PRODUCTS OR PICTURES WERE RETURNED WITH THE COMPLAINT TO AID IN THE INVESTIGATION. A SIMILAR COMPLAINTS SEARCH IN THE EQMS SYSTEM PERFORMED ON 24-JAN-2026 FOR AGAINST "LOT NUMBER" "6010934" AND SIMILAR MALFUNCTION CODE(S) : ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS AND ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO . NO SIMILAR COMPLAINTS WERE IDENTIFIED. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 24-JAN-2026 AGAINST "LOT NUMBER" "6010934" AND SIMILAR MALFUNCTION CODE(S) ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS AND ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO . NO RECORDS WERE FOUND WITH LOT 6010934 DIRECTLY REFERENCED. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION: DURING THE INVESTIGATION, A CAPA RELATED TO ADHESIVE ISSUES WAS IDENTIFIED. CAPA-2010953 WAS OPENED 18-SEP-2024 FOR ADHESIVE RELATED COMPLAINT AND BOUNDING COVERS MIO ADVANCE PRODUCTS AND THE TIME PERIOD REVIEW. SUMMARY CONCLUSION: BASED ON 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 SPAIN. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO ADHESIVE ON THE INFUSION SET COME OFF LEADING TO HYPERLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 260 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN PUMP. 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
    1309908 MINIMED MIO ADVANCE UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A UNKNOWN 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention