BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 22801027 · Received August 13, 2025

    Report

    Report Number
    2122870-2025-00091
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    QLC
    UDI-DI
    15099590201852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL IDENTIFIER FOR THIS REPORT IS CASE (B)(4). THE PATIENT IS A 38-YEAR-OLD FEMALE. A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE SAMPLE STATUS WAS NORMAL, WITH NO LIPEMIA, JAUNDICE OR HEMOLYSIS. THE SAMPLE WAS CENTRIFUGED ONLINE WITH THE DXA5000. THE LSS TRANSFERRED THE SERUM TO A NEW TUBE AND CENTRIFUGED IT AT HIGH SPEED (12000R, 10MIN), THEN RETESTED THE SAMPLE ON THE CUSTOMER'S DXI800 ANALYZER, THE RETEST RESULT WAS 1176.48PG/ML, THE RETEST RESULT WAS CONSISTENT WITH ORIGINAL RESULT. THE LSS ALSO COMPARED THE RE-CENTRIFUGED SAMPLE ON THE THIRD-PARTY PLATFORMS (B)(6), THE RESULTS ON THE SHENZHEN TIANCHEN INSTRUMENT WERE 3.02PG/ML AND 4.32PG/ML (REFERENCE RANGE: 0-7PG/ML) AND THE RESULTS ON THE ROCHE E601 INSTRUMENT WAS 14.3PG/ML (REFERENCE RANGE: 0-7PG/ML). ALTHOUGH THE ROCHE RESULT WAS SLIGHTLY HIGHER THAN THE REFERENCE RANGE, BUT THE CUSTOMER THOUGHT THE RESULT WAS ACCEPTABLE. THE LSS REQUESTED BLOCKERS AND FOLLOWED THE INTERFERENCE TESTING PROTOCOL, UNDER THE PASSING CALIBRATION CURVE AND QUALITY CONTROL. THE INTERFERENCE TESTING USING HETEROPHILE ANTIBODIES (GOAT IGG) AND ALKALINE PHOSPHATASE (SCAV-ALP + AP MUTEIN POOL) BLOCKERS WAS PERFORMED ON THE CUSTOMER'S DXI800 ANALYZER (SN # (B)(6). IT WAS FOUND THAT THE ELEVATED RESULT COULD NOT BE DECREASED BY ALL BLOCKERS. THE LSS PERFORMED PEG6000 (POLYETHYLENE GLYCOL) PRECIPITATION EXPERIMENT, THE SAMPLE RESULT DECREASED BY 84% AFTER PEG TREATMENT. THE PEG PRECIPITATION TEST INDICATED THE POSSIBLE PRESENCE OF MACROMOLECULAR SUBSTANCES. WHILE FOR THE PEG TESTING METHOD, THERE WAS NO VALIDATION FOR IT. THE LSS HAS COMMUNICATED WITH THE CUSTOMER ABOUT INTERFERENCE EXPERIMENT RESULT AND PEG PRECIPITATION TEST RESULT. THE CUSTOMER ACCEPTED. IN CONCLUSION, ALTHOUGH INTERFERENCE IS SUSPECTED, IT COULD NOT BE VERIFIED AS THE CAUSE OF THE MALFUNCTION DUE TO THE SAMPLE BEING TESTED WITH AN UNAPPROVED METHODOLOGY(PEG EXPERIMENT) AND INTERFERENCE TESTING DID NOT CONFIRM THE PRESENCE OF ANY INTERFERENCE. AN ASSIGNABLE CAUSE FOR THE DISCORDANCE MALFUNCTION CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. NOTE: ACCESS IL-6 PART NUMBER A16369 IS USED TO COMPLETE MDR REPORTING AS ACCESS IL-6 IS STILL EMERGENCY USE AUTHORIZATION WITHIN THE UNITED STATES. CUSTOMER IN COUNTRY OF EVENT ORIGIN IS USING ACCESS IL-6 PART NUMBER A16369 WHICH IS IS APPROVED IN THAT COUNTRY AS IN VITRO DIAGNOSTICS AND IS NOT UNDER EMERGENCY USE AUTHORIZATION.

    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 DXI800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(6). THE CUSTOMER SAID ONE 38-YEAR-OLD PATIENT WHICH WAS DIAGNOSED WITH SUDDEN HEARING LOSS. THE PATIENT'S IL-6 ORIGINAL RESULT WAS 1277.73PG/ML AND RETEST RESULT WAS 1212.97PG/ML, THE REFERENCE RANGE IS 0-7PG/ML. THE PATIENT'S ROUTINE BLOOD CRP RESULT WAS 0.0 MG/L, AND ADDITIONAL BIOCHEMICAL TESTS FOR CRP/PCT/SAA WERE ALL NEGATIVE, WITHIN THE REFERENCE RANGE. THE CUSTOMER SAID THAT THE ABNORMALLY HIGH IL-6 RESULT FOR THE PATIENT WAS NOT CONSISTENT WITH CLINICAL PRESENTATION. 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 CALIBRATION AT THE TIME OF THE EVENT PASS WITH THE EXPECTATION. 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
    1393754 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER, INC. 439963 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female