BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 21923968 · Received April 29, 2025

    Report

    Report Number
    3003442380-2025-07342
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Report Date
    May 15, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    K143446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: THE REFERENCE SAMPLES FOR THE LOT 6005634 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2062098 ON 30/NOV/2024. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) COMPLAINT TEST REPORT. THE REFERENCE SAMPLES WAS AIR FLOW TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005634 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 44 ON THE MULTIVAC 07, ON 09/FEB/2024, WITH A TOTAL OF (B)(4) UNITS. CANNULA DHR REVIEW: THE LOT 4A03934 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 ASSEMBLED IN THE LINE 2, ON 02/FEB/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 WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 14/MAY/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6005634 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6005634 AND MALFUNCTION CODE. 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 OTHER COMPLAINT RECEIVED ON 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 BRAZIL. THE PATIENT MOTHER REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE IN THE INFUSION SET TUBING BEHIND THE NEEDLE AT ABDOMEN. THE INFUSION SET WAS IN USE FOR THREE DAYS. 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
    1340366 ACCU-CHEK FLEXLINK AC FLEXLINK I 10/60 10PCS FPA UNOMEDICAL UM-D 04626516001 6005634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown