BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLINK ULTRAFLEX (ACCU-CHEK)

    MDR report key: 23484745 · Received November 6, 2025

    Report

    Report Number
    3003442380-2025-15935
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 10, 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

    E1: PATIENT CITY:(B)(6). PATIENT COUNTRY: BRAZIL.

    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001713, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 11-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6001713". NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. TEST RESULTS: NO SAMPLE WAS RETURNED, AS MENTIONED IN THE REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001713 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 81 AND PACKAGING IN THE MULTIVAC M07, ON 28/JUL/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. ASSEMBLY THE LOT 3F00253 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND ASSEMBLY ON MACHINE 02, ON 24/JUL/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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2022. THE LEAKAGE OCCURRED BETWEEN THE NEEDLE AND THE CANNULA HEAD. 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
    218555 FLEXLINK ULTRAFLEX (ACCU-CHEK) AC FLEXLINK I 10 10PCS. FPA UNOMEDICAL DEVICES S.A. DE C.V. 04626575001 6001713

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male