BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25077377 · Received May 5, 2026

    Report

    Report Number
    8021545-2026-06007
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 21, 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: (B)(6). 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. 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 AND ASSIGNED MALFUNCTION CODE INSERTION SITE EGRESS - NOT DEVICE RELATED IT HAS BEEN DETERMINED THE COMPLAINT DOES NOT ALLEGE A PRODUCT MALFUNCTION HAS OCCURRED. THEREFORE, NO FURTHER INVESTIGATION IS REQUIRED. CONCLUSION OF COMPLAINT INVESTIGATION: LOT NUMBER: 6011226 WAS PROVIDED, HOWEVER, AS NO PRODUCT MALFUNCTION WAS ALLEGED: NO VISUAL INSPECTION IS REQUIRED TO BE PERFORMED. NO RETAIN SAMPLE TESTING IS REQUIRED TO BE CONDUCTED. NO FURTHER ASSESSMENT WILL BE MADE REGARDING POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS. STERILIZATION REPORT: REVIEW OF THE STERILIZATION REPORT (B)(4) FOR THE LOT NUMBER: 6011226 SHOWED NO ISSUES. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION: BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION IS REQUIRED NOR IS A CAPA PLAN NEEDED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING (MONTHLY TRIPS AND ALERTS). SUMMARY CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION HAS BEEN PERFORMED, AND THE COMPLAINT COULD NOT BE CONFIRMED AS ANALYZED. THEREFORE, THE COMPLAINT IS CLOSED BASED ON THE EVENT DESCRIPTION AND ALL INFORMATION MADE AVAILABLE. 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 INFUSION SET LEAKAGE AT THE SITE ON (B)(6) 2026 AND THE PATIENT WAS EXPERIENCED SKIN IRRITATION AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555719 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431AG600 6011226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown