BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 21856084 · Received April 17, 2025

    Report

    Report Number
    3003442380-2025-06471
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 1, 2025
    Report Date
    June 11, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 6001496 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 16-OCT- 2024. COMPLAINT INVESTIGATION RESULTS: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. THE REVIEW FOR BATCH 5413183 WERE PREVIOUSLY REVIEWED IN COMPLAINT (B)(4) ON 15/MAY/2025. TEST RESULTS THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 2020710.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001496 WAS MANUFACTURED ACCORDING TO DHR VERSION 43 ON THE MULTIVAC 07, ON 02/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA DHR REVIEW: THE LOT 3E01811 WAS MANUFACTURED ACCORDING TO THEN WI VERSION 35 ASSEMBLED IN THE LINE 2, ON 27/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3F00226 WAS GLUED ACCORDING TO THE WI VERSION 21, LINE 7, ON 02 JUN 2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E01796 WAS GLUED ACCORDING TO THE WI VERSION 21, LINE 7, ON 18 MAY 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, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 15-MAY-2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6001496 WITH NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT, 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 RNO MORE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    TO DATE, NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025 . THE LEAKAGE WAS IN THE CANNULA. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29698 ACCU-CHEK FLEXLINK ACCU-CHEK FLEXLINK I 6/60 10 FPA UNOMEDICAL A/S 06593909001 6001496

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male