BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 10784031 · Received November 4, 2020

    Report

    Report Number
    2122870-2020-00092
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 4, 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

    THE FILL PATIENT IDENTIFIER IS (B)(6). THE EXACT NUMBER OF QUESTIONED PATIENT SAMPLES WAS NOT PROVIDED. THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, OR RACE. 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. APPLICATIONS SUPPORT OBSERVED AT LEAST ONE SAMPLE HAD BEEN DRAWN AT AN ALTERNATE SITE AND NOT SPUN PRIOR TO TRANSPORT TO THE CUSTOMER SITE. APPLICATIONS SUPPORT WAS UNABLE TO PROVIDE ADDITIONAL DETAILS SURROUNDING THE SAMPLE NOT SPUN PRIOR TO TRANSPORT TO THE CUSTOMER SITE. APPLICATIONS SUPPORT RECOMMENDED USERS FOLLOW THE PRE-ANALYTICAL GUIDELINE. ALTHOUGH APPLICATIONS SUPPORT RECOMMENDED USERS FOLLOW THE PRE-ANALYTICAL GUIDE, USE ERROR CANNOT BE CONFIRMED AS THE CUSTOMER DECLINED TO PROVIDE SAMPLE HANDLING CONDITION INFORMATION. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 1

    ON 20OCT2020, THE CUSTOMER REPORTED MULTIPLE ELEVATED IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 922188) PATIENT RESULTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE NUMBER OF SAMPLES AND SPECIFIC SAMPLE RECOVERY DETAILS OF THE QUESTIONED ELEVATED IL-6 RESULTS WERE NOT PROVIDED. THE CUSTOMER REPORTED THE QUESTIONED IL-6 RESULTS WERE RUN AT AN ALTERNATE SITE FOR CONFIRMATION PRIOR TO REPORTING RESULTS. SAMPLE RECOVERY DETAILS OF IL-6 RESULTS RUN AT THE ALTERNATE SITE WERE NOT PROVIDED IN THIS EVENT EITHER. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS, OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS OF PASSING SYSTEM CHECK, CALIBRATION, AND QUALITY CONTROL RECOVERY DID NOT DEMONSTRATE AN ISSUE WITH THE SYSTEM. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING, AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, 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
    1250519 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 922188 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1