BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 10839883 · Received November 13, 2020

    Report

    Report Number
    2122870-2020-00093
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    QLC
    UDI-DI
    15099590201852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE CUSTOMER TELEPHONE NUMBER IS (B)(6). (B)(4) THE ACCESS IL-6 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND DID NOT IDENTIFY ANY SYSTEM OR HARDWARE ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LIKELY CAUSE IS USE ERROR AS THE CUSTOMER DID NOT FOLLOW THE IFU (INSTRUCTIONS FOR USE) GUIDELINES FOR SPECIMEN PREPARATION. THE ACCESS IL-6 FOR USE ON THE UNICEL DXI SYSTEM INSTRUCTION FOR USE (IFU) (DOCUMENT A83714 M, AVAILABLE ON THE BECKMAN COULTER WEBSITE) STATES, ¿PHYSICALLY SEPARATE SERUM OR PLASMA FROM CONTACT WITH CELLS AS SOON AS POSSIBLE.¿

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE CUSTOMER REPORTED ERRONEOUS ERRATIC IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 922188) RESULTS FOR ONE PATIENT WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THE ERRATIC RESULTS WERE GENERATED FROM BOTH EDTA PLASMA AND SERUM SAMPLES. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE SAMPLES WERE TESTED ON (B)(6) 2020. THE SERUM SAMPLE YIELDED RESULTS OF 1020.29 PG/ML (14:25PM) AND 1049.29 PG/ML (15:15PM). THE EDTA PLASMA SAMPLE YIELDED A RESULT OF 2.12 PG/ML (TIME NOT PROVIDED). THE EXPECTED VALUES FOR THE ACCESS IL-6 ASSAY IS <6.4 PG/ML. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL HAVE BEEN PASSING WITHIN SPECIFICATION. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLES WERE EDTA PLASMA AND A SERUM SAMPLE COLLECTED IN A SERUM SEPARATOR TUBE (SST). OTHER SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305850 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 922188 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1