BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 21759767 · Received April 3, 2025

    Report

    Report Number
    3003442380-2025-05220
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    February 24, 2025
    Report Date
    May 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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 6001283 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2020721 ON 16/OCT/2024. 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 DATABASE (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001283 WAS MANUFACTURED ACCORDING TO THE WI VERSION 15 MANUFACTURED IN THE MULTIVAC 07, ON 05/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA DHR REVIEW: THE LOT 3D02666 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE LINE 02, ON 03/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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 28/APR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6001283 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001283 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE PMS PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR).

    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 6001283 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON (B)(6) 2024. 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 DATABASE (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001283 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 MANUFACTURED IN THE MULTIVAC 07, ON 05/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA DHR REVIEW: THE LOT 3D02666 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE LINE 02, ON 03/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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 28/APR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE AND LOT 6001283 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001283 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE PMS PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    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 CANNULA LEAKAGE EVENT ON (B)(6) 2025. 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
    1735786 ACCU-CHEK FLEXLINK AC FLEXLINK CANNULA 8 10PCS. FPA UNOMEDICAL DEVICES S.A. DE C.V. 04626567001 6001283

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female