BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 11847829 · Received May 19, 2021

    Report

    Report Number
    2122870-2021-00072
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 8, 2021
    Report Date
    May 19, 2021
    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 CASE( B)(6). THE EXACT NUMBER OF ELEVATED 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. ON (B)(6) 2021 (TWO DAYS AFTER THE EVENT) THE SYSTEM CHECK FAILED ON THE WASHED PORTION WITH A WASHED %CV AT 21.56% (AT 05:22 PM) BUT UPON REPEAT THE SYSTEM CHECK PASSED WITH A WASHED %CV AT 8.24% (AT 07:00 PM). THE SAME DAY, THE CUSTOMER RETESTED FIVE TIMES A PATIENT SAMPLE WITH ACCEPTABLE IL-6 RESULTS (6.36 PG/ML, 6.33 PG/ML, 6.46 PG/ML, 6.28 PG/ML AND 5.97 PG/ML). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 11MAY2021 AND COMPARED SEVEN (7) SAMPLES WITH OTHER CUSTOMER SITE USING SAME METHOD INSTRUMENT. ALL RESULTS WERE CONCORDANT. HE ALSO CHECKED CALIBRATION, QCS AND SYSTEM CHECK DATA. THE INSTRUMENT IS WORKING WITHIN SPECIFICATIONS. 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) 2021 THE CUSTOMER REPORTED MULTIPLE ELEVATED IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 124063) PATIENT RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). ON (B)(6) 2021 THE CUSTOMER REPORTED SEVERAL SAMPLES WERE RUN AT AN ALTERNATE SITE WITH LOWER RESULTS. THE EXACT NUMBER OF ELEVATED IL-6 SAMPLES RESULTS WAS NOT PROVIDED. NO DATA FROM ALTERNATE SITE WAS PROVIDED. 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. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 124063 AND CALIBRATOR LOT 922927. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2021. CUSTOMER WAS ASKED TO RUN A SYSTEM CHECK AFTER OBTAINING THE HIGH IL-6 RESULTS. ON (B)(6) 2021 THE SYSTEM CHECK FAILED ON THE WASHED PORTION WITH A WASHED %CV AT 21.56% (AT 05:22 PM). THE CUSTOMER REPEATED THE SYSTEM CHECK WHICH PASSED WITH A WASHED %CV AT 8.24% (AT 07:00 PM). THE CUSTOMER RETESTED FOR FIVE TIMES A SAMPLE WITH ACCEPTABLE IL-6 RESULTS (6.36 PG/ML, 6.33 PG/ML, 6.46 PG/ML, 6.28 PG/ML AND 5.97 PG/ML). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 11MAY2021 AND COMPARED SEVEN (7) SAMPLES WITH OTHER CUSTOMER SITE USING SAME METHOD INSTRUMENT. ALL RESULTS WERE CONCORDANT. HE ALSO CHECKED CALIBRATION, QCS AND SYSTEM CHECK DATA. ALL PASSED. 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
    748361 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN 6 QLC BECKMAN COULTER 124063 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1