BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6

    MDR report key: 13002980 · Received December 14, 2021

    Report

    Report Number
    2122870-2021-00181
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 14, 2021
    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

    THE FULL IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS IL-6 ASSAY WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. NO OTHER ASSAY ISSUES WERE REPORTED. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS OF CALIBRATION AND QUALITY WERE NOT PROVIDED FOR REVIEW. WHILE ONSITE, THE LABORATORY SOLUTIONS SPECIALIST (LSS) TESTED THE PATIENT SAMPLE ON THE ROCHE PLATFORM AND OBTAINED RESULTS WHICH WERE ABOVE THE NORMAL REFERENCE RANGE. THE LSS COMMUNICATED WITH THE CUSTOMER THAT THE RESULTS ON THE ROCHE PLATFORM WERE ALSO CONSIDERED POSITIVE RESULTS. THE LSS ALSO NOTED THAT THE RESULTS ON THE PLATFORM WERE RISING, AND THAT THE BECKMAN RESULTS WERE CONSISTENT WITH THE OTHER METHODOLOGIES. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED A QUESTIONED ELEVATED IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 124662) PATIENT RESULT WAS GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4))). THE CUSTOMER REPORTED THE HIGH ACCESS IL-6 RESULT WAS HIGHER THAN COMPETITOR IL-6 ASSAY RESULTS. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. 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 WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE HANDLING INFORMATION INCLUDING SAMPLE TYPE, COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. A BECKMAN COULTER LABORATORY SUPPORT SPECIALIST (LSS) WAS DISPATCHED TO ASSESS ASSAY AND SYSTEM PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897019 ACCESS IL-6 IMMUNOASSAY METHOD, INTERLEUKIN QLC BECKMAN COULTER 124662 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown