BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 20322995 · Received September 27, 2024

    Report

    Report Number
    8021545-2024-03930
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 9, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022836
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: UNITED STATES.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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: (B)(4). THE BATCH 6003301, IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6003301". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003301 WAS MANUFACTURED ACCORDING TO APPENDIX 1 BATCH CARD FOR PRODUCTION OF PACKAGING - PACKAGING ROOM REV [79] ON 16-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR 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. TEST RESULTS: NO PHOTO OR PRODUCT WERE RETURNED TO COMPLETE TESTING. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING FROM QUICK RELEASE SITE AND PATIENT HAD HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2024, THEREFORE SENSOR WAS UPDATING AND CHANGE SENSOR ALERT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 4 DAYS. 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
    1372892 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-442A 6003301 05705244022836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown