BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25316889 · Received May 28, 2026

    Report

    Report Number
    8021545-2026-10554
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 19, 2026
    Report Date
    May 3, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018907
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF INVESTIGATION FINDINGS CODE C22 (APPROPRIATE TERM/CODE NOT AVAILABLE) HAS BEEN SELECTED, AS CODE C24 IS NOT AVAILABLE IN THE DATABASE TO CAPTURE (MALFUNCTION OBSERVED WITHOUT CONCLUSIVE FINDING). IMDRF CAUSE CONCLUSION CODE D17 (APPROPRIATE TERM/CODE NOT AVAILABLE) HAS BEEN SELECTED, AS CODE D1501 IS NOT AVAILABLE IN DATABASE TO CAPTURE (CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY). 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 6013047 WAS PROVIDED. COMPLAINT WAS CLASSIFIED REPORTABLE UNDER MALFUNCTION CODE CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION: DURING THE INVESTIGATION CAPA-2010953 WAS IDENTIFIED, IT WAS OPENED 18-SEP-2024 FOR ADHESIVE RELATED COMPLAINTS AND BOUNDING COVERS MINI MED MIO ADVANCE PRODUCTS AND THE TIME PERIOD REVIEWED. 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: ALL CORRECTIVE ACTIONS RELATED TO MINIMED MIO ADVANCE HAVE BEEN IMPLEMENTED. SUMMARY CONCLUSION: BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION HAS BEEN COMPLETED AND ALL APPLICABLE REQUIREMENTS WERE REVIEWED AND FOUND TO BE MET. THE COMPLAINT IS CONFIRMED, AS THE ALLEGED MALFUNCTION IS CONSISTENT WITH A KNOWN ISSUE THAT IS BEING ADDRESSED UNDER THE PRE EXISTING CAPA 2010953. AS THIS COMPLAINT FALLS WITHIN THE SCOPE OF THE IDENTIFIED TREND, NO FURTHER COMPLAINT SPECIFIC INVESTIGATION WILL BE CONDUCTED. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486528 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-243A 6013047 05705244018907

    Patients

    Seq Age Sex Outcome Treatment
    1