BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 22068816 · Received May 22, 2025

    Report

    Report Number
    8021545-2025-01108
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 22, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023406
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    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 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. THE REFERENCE SAMPLES FOR THE LOT 6010946 HAVE BEEN TESTED IN TRACKWISE RECORD COMPLAINT (B)(4) ON 15-JUL-2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND FLOW TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010946 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 80 APPENDIX 1 BATCH CARD FOR PRODUCTION OF PACKAGING ROOM ON 25-JAN-2025, 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. TRENDING: A QUERY WAS RUN IN DATABASE ON 10-JUL-2025 AGAINST MALFUNCTION CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT, WITH 2 SIMILAR COMPLAINTS IDENTIFIED. NO HARMS ASSOCIATED WITH THE OTHER 2 COMPLAINTS. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025 AND EVENTUALLY GOT HOSPITALIZED. THE BLOOD GLUCOSE LEVEL WAS 544 MG/DL AT THE TIME OF EVENT. NO FURTHER INFORMATION WAS 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
    2321212 MEDTRONIC EXTENDED EWIS BLUE 60/6 HCAP 5-PACK FPA UNOMEDICAL A/S MMT-431AG 6010946 05705244023406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention