BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 25010461 · Received April 27, 2026

    Report

    Report Number
    2122870-2026-00017
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    QLC
    UDI-DI
    15099590201852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY GOT FALSE HIGH ACCESS IL-6(ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 439963) RESULT FOR ONE PATIENT SAMPLE ON THEIR DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(6)). THE PATIENT¿S IL-6 RESULT WAS GREATER THAN 4500 PG/ML, EXCEEDING THE UPPER LIMIT OF THE REFERENCE RANGE (<6.4 PG/ML). AS THE PATIENT HAD RECEIVED SYLVANT SILTUXIMAB TREATMENT PRIOR TO TESTING IN ACCORDANCE WITH CLINICAL REQUIREMENTS, CLINICIANS CONSIDERED A LOWER IL-6 VALUE TO BE MORE CONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION. THE PATIENT SAMPLE WAS SENT TO FLOW CYTOMETER FOR TESTING, THE IL-6 RESULT WAS 1.1 PG/ML WHICH WAS NORMAL AND MET THE CLINICAL PROFILE. THERE WAS NO REPORT OF INJURY AND NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QC (QUALITY CONTROL) AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEWING NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. A BECKMAN COULTER LSS (LABORATORY SOLUTION SPECIALIST) WAS DISPATCHED TO CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272412 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER, INC. 538720 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown