BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 25077086 · Received May 5, 2026

    Report

    Report Number
    8021545-2026-06025
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    October 3, 2025
    Report Date
    April 22, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: GUELPH. PATIENT COUNTRY: CANADA. NAME: MEDTRONIC MINIMED. COUNTRY: UNITED STATES OF AMERICA. STREET: 18000 DEVONSHIRE STREET. CITY: NORTHRIDGE. STATE, PROVINCE OR TERRITORY: CALIFORNIA. POST OFFICE OR ZIP CODE: 91325. IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW. 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 6012759 WAS PROVIDED. COMPLAINT WAS CLASSIFIED AS A SERIOUS INJURY UNDER MALFUNCTION CODE: ADHESIVE PATCH COMPLETELY DETACHES DURING USE - DETACHMENT / SIGNIFICANT WETNESS. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON (B)(6) 2026 AGAINST "LOT NUMBER" "6012759" AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH COMPLETELY DETACHES DURING USE - DETACHMENT / SIGNIFICANT WETNESS, ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO ADHESIVE PATCH ANOMALY. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE) RECORD DATABASE (B)(4) WERE IDENTIFIED FOR THIS LOT AND SIMILAR RELATED ISSUES. AS THE COUNT OF COMPLAINTS IS 2, WHICH IS BELOW STATED THRESHOLD OF 3, NO STATISTICAL TRENDING ANALYSIS IS REQUIRED. A NON-CONFORMANCE (NC)/CORRECTIVE AND PREVENTIVE ACTION (CAPA) QUERY SEARCH WAS RUN IN THE EQMS SYSTEM PERFORMED ON (B)(6) 2026 AGAINST "LOT/BATCH NUMBER" "6012759". NO RECORDS WERE FOUND. BATCH RECORD REVIEW: SUB ASSEMBLY BATCH RECORD WITH LOT 5C05700 AND 5C05701 FOR THE MAIN BATCH RECORD WITH LOT 6012759 WERE REVIEWED. REVIEW OF THE SUB-ASSEMBLY DOCUMENTATION 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. SAMPLE TESTING: NO PRODUCTS OR PICTURES WERE RETURNED WITH THE COMPLAINT TO AID IN THE INVESTIGATION. NO PRODUCT TESTING WILL BE PERFORMED. NO FURTHER ASSESSMENT WILL BE MADE REGARDING POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS. FURTHER EVALUATION AND ACTIONS RELATED TO THE ADHESIVE ISSUE ARE BEING ADDRESSED UNDER THE PRE-EXISTING CAPA-2010953. CAPA DETERMINATION: DURING THE INVESTIGATION CAPA-2010953 WAS IDENTIFIED, IT WAS OPENED (B)(6) 2024 FOR ADHESIVE RELATED COMPLAINTS AND BOUNDING COVERS MEDTRONIC EXTENDED (EWIS) PRODUCTS AND THE TIME PERIOD REVIEWED. ROOT CAUSE OF PROBLEM: CUSTOMER COMPLAINT REPORTING FOR EWIS INCLUDES A LARGE NUMBER OF REPORTS RELATED TO ACCIDENTAL MISUSE WHERE THE INFUSION SET, AND ADHESIVE PATCH HAVE BEEN ACCIDENTALLY PULLED OFF DURING ITS EXTENDED PERIOD OF WEAR (COMPARED TO 3-DAY ADHESIVES). THIS IS NOT A RESULT OF THE DESIGN AND MANUFACTURING OF THE ADHESIVE AND ARTIFICIALLY INCREASE THE OVERALL COMPLAINT DATA FOR EWIS. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: DATABASE (B)(4) OPENED TO REVIEW AND UPDATE EWIS RISK MANAGEMENT FILE WITH UPDATED TEST RESULTS, AND TO CORRECTLY MAP HARMS AND SEVERITIES IN LINE WITH IC PORTFOLIO. 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 SERIOUS INJURY. 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 INFUSION SET CAME OFF ON (B)(6) 2025 DUE TO TAPE NOT STICKING. THE PATIENT WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND TREATED WITH INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538171 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431AG600 6012759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown