BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 10725972 · Received October 23, 2020

    Report

    Report Number
    2122870-2020-00090
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 23, 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 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. ALTHOUGH A USE ERROR MAY HAVE CONTRIBUTED TO THIS ISSUE AS PER THE LOCAL FIELD SERVICE ENGINEER DISPATCHED ON SITE, THE CUSTOMER NEEDED TO BE TRAINED FOR SAMPLE STABILITY, AND PRE-ANALYTICAL PROCEDURES, THERE IS NOT ENOUGH EVIDENCE TO CORROBORATE THIS STATEMENT. THERE IS NO INFORMATION ABOUT THE CUSTOMER¿S SAMPLE STORAGE AND OTHER PATIENT SAMPLE RESULTS WERE STATED APPROPRIATE EVEN IF THE DAILY MAINTENANCE WAS NOT PERFORMED. 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 (B)(6) 2020, THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 922188) RESULTS FOR ONE PATIENT SAMPLE WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE SPECIFIC SAMPLE WAS PROCESSED FIVE DAYS AFTER COLLECTION WITH AN UNEXPECTED HIGH RESULT OF 310.6 PG/ML ON (B)(6) 2020. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2020, AND ONCE ON (B)(6) 2020 WITH THE SAME RESULT OF > 1624 PG/ML (OVER THE RANGE RESULTS). FINALLY THE SAMPLE WAS RUN ON 08OCT2020 WITH THE ONBOARD DILUTION WITH A RESULT OF 2239.77 PG/ML. THE EXPECTED VALUES FOR THE ACCESS IL-6 ASSAY IS <6.4 PG/ML. 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. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. HOWEVER, THE SAMPLE WAS FOUND HEMOLYZED BY THE LOCAL FIELD SERVICE ENGINEER (FSE) DISPATCHED ON SITE ON (B)(6) 2020. 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
    1196117 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 922188 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1