BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 21940928 · Received May 1, 2025

    Report

    Report Number
    8021545-2025-00885
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    March 24, 2025
    Report Date
    November 7, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: NETHERLANDS.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001989 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001989 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 20-JUL-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 PRODUCT WAS RETURNED. 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, 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 NETHERLANDS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF INFUSION SET TUBING DETACHMENT ON (B)(6) 2025. THE LOCATION OF INFUSION SET WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. THE EVENT OCCURED DURING SLEEPING. 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
    208620 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6001989 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown