BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6

    MDR report key: 12915906 · Received December 2, 2021

    Report

    Report Number
    2122870-2021-00176
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    QLC
    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 CUSTOMER DID NOT PROVIDE A ACCESS IL-6 REAGENT LOT NUMBER; THEREFORE, DATE OF MANUFACTURE, DATE OF EXPIRATION AND UDI COULD NOT BE OBTAINED. 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) PERFORMED INTERFERENCE TESTING WITH THE PATIENT SAMPLE. INTERFERENCE TESTING DID NOT INDICATE A PATIENT SOURCED INTERFERENT WAS PRESENT IN THE PATIENT SAMPLE. THE LSS ALSO TESTED THE PATIENT SAMPLE ON A DXI 800 ACCESS 2 ANALYZER (PART NUMBER AND SERIAL NUMBER NOT PROVIDED) AT A DIFFERENT HOSPITAL. THE TEST RESULT OBTAINED ON THE ALTERNATE DXI 800 WAS CONSISTENT WITH THE ORIGINAL RESULT. 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 A30945, LOT NUMBER NOT PROVIDED) PATIENT RESULT OF 1327 PG/ML WAS GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4))). THE CUSTOMER INDICATED THAT THE CLINICIAN BELIEVED THE RESULT WAS TOO HIGH AND DID NOT MATCH THE PATIENT SYMPTOMS. 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
    1813956 ACCESS IL-6 IMMUNOASSAY METHOD, INTERLEUKIN QLC BECKMAN COULTER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown