BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 22865223 · Received August 21, 2025

    Report

    Report Number
    2122870-2025-00092
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 12, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    QLC
    UDI-DI
    15099590201852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 30JUL2025, THE CUSTOMER REPORTED ERRATIC IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 538411) RESULTS FOR ONE PATIENT WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 600 IMMUNOASSAY ANALYZER (PART NUMBER A30260 SERIAL NUMBER (S/N) (B)(6)). THE FOLLOWING IL6 RESULTS WERE OBTAINED FOR ONE PATIENT SAMPLE (SAMPLE ID: (B)(6)): > 1599.0 PG/ML (OVR FLAG) ON (B)(6) 2025 AT 5:11 PM. < 1275.0 PG/ML (AUTOMATED DILUTED TEST, RFX FLAG) ON (B)(6) 2025 AT 5:42 PM. 7.8 PG/ML (MANUAL DILUTION WITH A DILUTION FACTOR OF 10) ON (B)(6) 2025 AT 6:20 PM. > 1599.0 PG/ML (OVR FLAG) ON (B)(6) 2025 AT 7:12 PM. < 1275.0 PG/ML (AUTOMATED DILUTED TEST, RFX FLAG) ON (B)(6) 2025 AT 7:44 PM. 97.2 PG/ML ON (MANUAL DILUTION WITH A DILUTION FACTOR OF 3) (B)(6) 2025 AT 8:28 PM. > 1599.0 PG/ML (OVR FLAG) ON (B)(6) 2025 AT 7.11 AM. < 1275.0 PG/ML (AUTOMATED DILUTED TEST, RFX FLAG) ON (B)(6) 2025 AT 7:43 AM. 1736.3 PG/ML (MANUAL DILUTION WITH A DILUTION FACTOR OF 2) ON (B)(6) 2025 AT 8:23 AM. THE CUSTOMER HAD TO PERFORM MULTIPLE MANUAL DILUTIONS TO OBTAIN A RESULT AS THE RESULTS OBTAINED WITH THE REFLEX TEST WERE DISCORDANT WITH THOSE OBTAINED WITHOUT DILUTION. THE CUSTOMER RELEASED THE RESULT OF 1736.3PG/ML WITH DILUTION FACTOR OF 2. THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. NO CHANGE IN THE PATIENT TREATMENT WAS REPORTED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED WITHIN SPECIFICATION IN ALL PORTIONS ON (B)(6) 2025. CALIBRATION PASSED ON (B)(6) 2025 USING REAGENT LOT 538411 AND CALIBRATOR LOT 440377. QUALITY CONTROL (QC) WERE WITHIN LABORATORY¿S EXPECTED RANGES. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442849 ACCESS IL-6 REAGENT INTERLEUKIN 6 QLC BECKMAN COULTER INC. 538411 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown