BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2846033 · Received November 26, 2012

    Report

    Report Number
    2122870-2012-01890
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    June 7, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON BEC INVESTIGATION, IT WAS NOTED THAT THE CUSTOMER IS SUSPECTING THE PATIENT'S RESULTS HAVE BEEN IMPACTED BY AN INTERFERING SUBSTANCE (PARTICULARLY A HIGH WHITE BLOOD CELL COUNT) WHICH IS NOT LISTED IN THE FOLATE ASSAY IFU AS A KNOWN INTERFERENT. THE CUSTOMER REPORTED THE PATIENT HAS BEEN DIAGNOSED WITH CHRONIC MYELOID LEUKEMIA CATEGORIZED BY INCREASED AND UNREGULATED GROWTH OF WHAT ARE TYPICALLY MYELOID CELLS IN THE BONE MARROW AND THE ACCUMULATION OF THESE CELLS IN THE BLOOD (OTHERWISE KNOWN AS "CANCER OF WHITE BLOOD CELLS" OR CHRONIC GRANULOCYTIC LEUKEMIA (CGL)). CURRENTLY IT DOES NOT APPEAR THE CUSTOMER IS ACCEPTING THE PATIENT'S RBC FOLATE RESULTS AS VALID (THE CUSTOMER DID OBTAIN QUANTIFIABLE RESULTS OFF THE CALIBRATION CURVE FROM THE SAMPLE AFTER IT WAS DILUTED 1:5) SINCE THEY ARE QUESTIONING THE RESULTS AS BEING IMPACTED BY INTERFERING SUBSTANCES. THE CUSTOMER INDICATED THEY WOULD LIKE TO SEND IN PATIENT SAMPLES FOR INVESTIGATIVE TESTING BUT THEY DO NOT HAVE ENOUGH SAMPLE REMAINING FROM THIS PATIENT TO SEND IN FOR SUCH TESTING. THE CUSTOMER CONTACTS HAVE INDICATED THE CUSTOMER IS PLANNING TO SEND IN PATIENT SAMPLES FOR INVESTIGATIVE TESTING SHOULD THEY OBTAIN SIMILAR RESULTS GOING FORWARD FOR THIS PATIENT OR A DIFFERENT PATIENT. THE CUSTOMER DID SUPPLY ADDITIONAL PATIENT RESULT DATA FROM SEVERAL DIFFERENT PATIENTS THAT WERE NOT DOCUMENTED AS BEING IN QUESTION INDICATING THE ASSAY WAS PRODUCING VALID RESULTS FOR OTHER PATIENTS TESTED AT THAT TIME. SYSTEM DATA HAS NOT BEEN SUPPLIED TO DATE (QC, SYSTEM CHECKS) AND PATIENT SAMPLE PROCESSING INFORMATION HAS NOT BEEN SUPPLIED TO DATE (CENTRIFUGATION TIME AND SPEED). THE CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN AND COULD NOT BE DETERMINED. THERE WAS INSUFFICIENT EVIDENCE SUPPLIED TO DETERMINE THE CAUSE OF THE RBC FOLATE PATIENT RESULTS IN QUESTION. THE PATIENT RESULTS IN QUESTION WERE GENERATED FROM A PATIENT DIAGNOSED WITH CHRONIC MYELOID LEUKEMIA AND THE CUSTOMER SUSPECTED SAMPLE SOURCED INTERFERENCE MAY HAVE IMPACTED THE PATIENT'S RESULTS. THE CUSTOMERS SUSPICIONS WERE UNABLE TO BE CONFIRMED OR REFUTED SINCE THERE WAS NO PATIENT SAMPLE AVAILABLE FOR REPEAT TESTING OR ADDITIONAL INVESTIGATIVE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THEY HAD OBTAINED RED BLOOD CELL FOLATE (RBC FOLATE) PATIENT RESULTS THAT WERE GREATER THAN THE REPORTABLE RANGE OF THE CURVE GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER THEN DILUTED THE RBC FOLATE SAMPLE 1:2 PER THE ASSAY IFU AND REPEATED TESTING OF THE PATIENT SAMPLE AND OBTAINED A RESULT THAT WAS STILL NOT WITHIN THE RLU RANGE OF THE CALIBRATION CURVE SO THE CUSTOMER FURTHER DILUTED THE SAMPLE 1:5 AND THEY WERE ABLE TO OBTAIN RESULT OF 44.97 NMOL/L WHICH WAS WITHIN THE MEASURING RANGE OF THE CUSTOMER'S ACTIVE CALIBRATION CURVE. THE CUSTOMER INDICATED THERE WERE NO CHANGES IN PATIENT TREATMENT IN CONNECTION TO THIS EVENT. THE CUSTOMER IS QUESTIONING THE VALIDITY OF THE RBC FOLATE RESULTS GENERATED FROM THE PARTICULAR PATIENT SAMPLE ARE ALSO SUSPECTING THE PATIENTS RESULTS MAY HAVE BEEN IMPACTED BY AN INTERFERING SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1