BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 22200148 · Received June 13, 2025

    Report

    Report Number
    3003442380-2025-10593
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    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 THE REFERENCE SAMPLES FOR THE LOT 6001491 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 03/APR/2025. THE REFERENCE SAMPLES WERE VISUAL INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT (B)(4) COMPLAINT TEST REPORT.PDF ATTACHED IN THIS RECORD. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. NOTE: 5/10 REFERENCE SAMPLES WERE NOT ABLE TO BE TESTED FOR FLOW DUE TO THE SAMPLES WERE USED IN A SPECIAL INVESTIGATION UNDER CAPA 1999254. DEVICE HISTORY RECORD (DHR) REVIEW: PACKAGING: THE LOT 6001491 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 43 ON THE PACKING PROCESS IN THE LINE MULTIVAC 07, ON 25/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA ASSEMBLY: THE LOT 3E01805 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 35 IN LINE 2 ON 19 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 17-JUN-2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6001491 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE 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

    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 THREE INFUSION SET LEAKAGE IN (B)(6) 2025 THE LEAKAGE WAS FROM THE CANNULA. THE BLOOD GLUCOSE LEVEL WAS 390 MG/DL. NO FURTHER INFORMATION IS AVALIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552261 ACCU-CHEK FLEXLINK AC FLEXLINK CANNULA 10 10PCS. FPA UNOMEDICAL DEVICES S.A. DE C.V. 04626575001 6001491

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female