BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 17395153 · Received July 26, 2023

    Report

    Report Number
    2122870-2023-00085
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BECKMAN COULTER
    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

    ON (B)(6) 2023 THE CUSTOMER REPORTED QUESTIONING ONE ELEVATED IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 337905) RESULT GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(6)). ON (B)(6) 2023, THE CUSTOMER OBTAINED ONE ELEVATED IL-6 PATIENT RESULT (OVER THE REPORTABLE RANGE: >1649 PG/ML) AND REPORTED QUESTIONING THIS ELEVATED RESULT AS THE PATIENT WAS PREVIOUSLY TESTED ON (B)(6) 2023 AND THE RESULT WAS AT 76.98 PG/ML. 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 PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEW. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED ON CUSTOMER'S SITE. THE LSS RETESTED THE QUESTIONED SAMPLE WITH AN ALTERNATE METHODOLOGY (LIFOTRONIC) WITH A CONCORDANT IL-6 RESULT >5000 PG/ML. THE SAMPLE WAS THEN MANUALLY DILUTED AND RETESTED WITH A RESULT >4947 PG/ML. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. HOWEVER THE CUSTOMER REPORTED THAT THE SAMPLE WAS COLLECTED ON (B)(6) 2023 AND STORED ON THE ORIGINAL SAMPLE TUBE. PER THE ACCESS IL-6 INSTRUCTIONS FOR USE (PART NUMBER A83733 J) IT STATES: "PHYSICALLY SEPARATE SERUM OR PLASMA FROM CONTACT WITH CELLS AS SOON AS POSSIBLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645798 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 337905 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown