BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYMAG® INSTRUMENT

    MDR report key: 23200119 · Received October 2, 2025

    Report

    Report Number
    9615037-2025-00037
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BIOMÉRIEUX ITALIA S.P.A
    Product Code
    JJH
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER FROM THE UNITED STATES WHO OBTAINED ¿VOLUME ERRORS W4711-LLS ERRORS¿ WHEN EXTRACTING PATIENT SAMPLE WITH EASYMAG INSTRUMENT (REF. 200111, SERIAL NUMBER: (B)(6) LEADING TO DELAYED RESULT. THE EASYMAG LOG WAS ANALYZED BY BIOMÉRIEUX GLOBAL CUSTOMER SERVICE, AND IT WAS DETERMINED THAT THE PROBLEM WAS OCCURRING AT DIFFERENT DISPENSE STEPS AND ON ERRATIC POSITIONS. INDEED, THE CUSTOMER HAD MULTIPLE INVALID EXTRACTIONS BY ERRORS ¿47XX¿ SINCE BEGINNING OF (B)(6) 2025: 92 EXTRACTIONS FAILED AFTER REAGENT BOTTLE C (EXTRACTION BUFFER 2) DISPENSE AND 15 EXTRACTIONS FAILED AFTER REAGENT BOTTLE D (EXTRACTION BUFFER 3) DISPENSE. THIS BEHAVIOR IS ASCRIBABLE TO THE LLS SYSTEM. BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AT CUSTOMER SITE AND CHECKED EASYMAG INSTRUMENT (REF. 200111, SERIAL NUMBER: (B)(6). BIOMÉRIEUX FSE REPLACED THE LLS TRANSMITTER AND THE FFC CABLE. FOLLOWING THESE ACTIVITIES, THE FSE WAS ABLE TO RUN INSTRUMENT PROTOCOLS WITHOUT ERROR. DUE TO THE AGE OF EASYMAG INSTRUMENT S/N (B)(6), THE ENCOUNTERED PROBLEM IS INSIDE THE NORMAL FAILURE RATE OF THESE COMPONENTS. IN CONCLUSION, THE ROOT CAUSE OF THE ¿VOLUME ERRORS W4711-LLS ERRORS¿ WAS RELATED TO A MALFUNCTION IN THE LLS SYSTEM, EXACERBATED BY THE AGE OF THE INSTRUMENT'S COMPONENTS.

    Description of Event or Problem · 0

    PRODUCT DESCRIPTION: THE NUCLISENS® EASYMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE AND IS INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS. FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE NUCLISENS® EASYMAG® PLATFORM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING ¿VOLUME ERRORS W4711-LLS ERRORS¿ WHEN EXTRACTING PATIENT SAMPLE WITH EASYMAG INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6)) LEADING TO DELAYED RESULT. CUSTOMER OBTAINED ¿VOLUME ERRORS W4711-LLS ERRORS¿ WHEN EXTRACTING PATIENT SAMPLE WITH EASYMAG INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6)). DUE TO THIS ISSUE, THE CUSTOMER CLAIMED FOR A DELAYED IN REPORTING PATIENT RESULTS OVER 24 HOURS. THE NUMBER OF IMPACTED SAMPLES WAS NOT INDICATED. ERROR CODE STARTING WITH 47XX, WHICH INCLUDED CUSTOMER ERROR CODE ¿W4711-LLS ERRORS¿, MEANS THAT ERROR OCCURRED AFTER A BUFFER DISPENSE, NOT ENOUGH VOLUME OF BUFFER DETECTED IN THE VESSEL. THE CORRESPONDING WELL HAS BEEN INVALIDATED AND NO FURTHER ACTIONS WILL BE PERFORMED IN THIS WELL BY THE INSTRUMENT. BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AT CUSTOMER SITE AND CHECKED EASYMAG INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6)). THE FSE TROUBLESHOOTED THE INSTRUMENT AND PERFORMED REPAIRS. FOLLOWING THESE ACTIVITIES, THE FSE WAS ABLE TO RUN INSTRUMENT PROTOCOLS WITHOUT ERROR. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAYED RESULT LED TO ANY ADVERSE EVENT RELATED TO PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451188 EASYMAG® INSTRUMENT EASYMAG® INSTRUMENT JJH BIOMÉRIEUX ITALIA S.P.A 200111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown