BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 19325458 · Received May 15, 2024

    Report

    Report Number
    2122870-2024-00022
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    May 12, 2024
    Report Date
    May 15, 2024
    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

    A1: THE FULL IDENTIFIER FOR THIS REPORT IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: THE ACCESS IL-6 REAGENT WAS NOT RETURNED FOR EVALUATION. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO ASSESS SYSTEM PERFORMANCE. WHILE ONSITE, LSS PERFORMED SEVERAL STUDIES WITH THE PATIENT SAMPLE (DETAILS OF TEST RESULTS IN SECTION B6). LSS ALSO PERFORMED TESTING USING QUALITY CONTROL (QC) MATERIAL AND OBTAINED ACCEPTABLE RESULTS. LSS DID NOT IDENTIFY ANY HARDWARE OR REAGENT ISSUES. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. NOTE: ACCESS IL-6 PART NUMBER A30945 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 OBTAINING ERRONEOUS ELEVATED IL-6 (ACCESS IL-6, PART NUMBER A16369 AND LOT NUMBER 338256) FOR ONE PATIENT ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(6)). THE ERRONEOUS ELEVATED IL-6 RESULT OF 81.91 PG/ML WAS RELEASED FROM THE LABORATORY. 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. CALIBRATION WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. OTHER SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND QUALITY CONTROL WERE NOT AVAILABLE FOR REVIEW. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO ASSESS SYSTEM PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669136 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 338256 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown