BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 22312815 · Received June 24, 2025

    Report

    Report Number
    8021545-2025-01569
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 4, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244025370
    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 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED. THE REFERENCE SAMPLES FOR THE LOT 6011306 HAVE BEEN TESTED IN TRACKWISE RECORD COMPLAINT (B)(6) ON (B)(6) 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND FLOW TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 2259563 COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011306 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 80 APPENDIX 1 BATCH CARD FOR PRODUCTION OF PACKAGING ROOM ON 03-FEB-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 SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6011306, WITH NO TREND IDENTIFIED. 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 GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA/ DIABETIC KETOACIDOSIS (DKA) AND BENT CANNULA EVENT. BLOOD GLUCOSE LEVEL WAS 503 MG/DL AT THE TIME OF THE EVENT. PATIENT GOT TREATED WITH INSULIN VIA MANUAL INJECTION. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS ALSO EXPERIENCED THE SYMPTOMS OF SICK/UNWELL, HEADACHE, TIRED/WEAK, AND INCREASED THIRST. 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
    1671258 MEDTRONIC EXTENDED EWIS BLUE 60/6 HCAP 4-PACK FPA UNOMEDICAL A/S MMT-431AK 6011306 05705244025370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R