BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2448326 · Received February 13, 2012

    Report

    Report Number
    2122870-2012-00292
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THE ISSUE. THE FIELD SERVICE ENGINEER (FSE) FSE REPLACED ALL OF THE PERI-PUMP TUBING AND VERIFIED PROPER ASPIRATION FOR ALL THREE OF THE ASPIRATE PROBES. THE FSE REPLACED THE SUBSTRATE VALVE, THE SUBSTRATE PROBE AND THE ON-BOARD SUBSTRATE, AND REMOVED AND CLEANED THE SUBSTRATE FITTINGS. THE FSE REPLACED THE SUBSTRATE PUMP, SUBSTRATE SUPPLY LINE AND THE SUBSTRATE PROBE. THE FSE CLEANED THE WASH WHEEL AND PERFORMED THE NECESSARY DISPENSE PLATE ALIGNMENTS. AFTER THE NECESSARY REPAIRS THE FSE COMPLETED A SYSTEM CHECK, ROUTINE SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK AND ASSAY QUALITY CONTROL ASSESSMENT WHICH ALL GENERATED ACCEPTABLE RESULTS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. HARDWARE IS THE LIKELY CAUSE OF THIS EVENT, HOWEVER THE SPECIFIC HARDWARE MALFUNCTION CONTRIBUTING TO THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012, HIGHER THAN EXPECTED CREATINE KINASE-MB ISOENZYME (CK-MB) AND PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE GENERATED FROM A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR THREE PATIENT SAMPLES. ONE OF THE ERRONEOUS CK-MB RESULTS WAS REPORTED OUTSIDE OF THE LABORATORY, THE OTHER TWO RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. WHILE THERE WERE NO REPORTS OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN AS TO WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT DUE TO THE ONE RELEASED CK-MB RESULT. INSTRUMENT ASSAY QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN THE LABORATORY'S ESTABLISHED RANGES PRIOR TO THE EVENT. HOWEVER, AFTER THE EVENT, THE CUSTOMER PERFORMED ASSAY QC AGAIN AND OBTAINED SEVERAL FAILING QC RESULTS ACROSS MULTIPLE ASSAYS. IN ADDITION, SUBSTRATE DISPENSE FAILURE, SAMPLE PIPETTOR RF LEVEL SENSE FAILURE AND SUBSTRATE BUBBLE DETECTED FAILURE ERROR MESSAGES WERE POSTED TO THE INSTRUMENT EVENT LONG AT THE TIME OF THE EVENT. THE CK-MB AND PSA SAMPLES WERE ANALYZED AGAIN ON ANOTHER INSTRUMENT. UPON REPEAT, BOTH CK-MB SAMPLES PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, AND THE PSA SAMPLE PRODUCED A LOWER RESULT WITHIN THE SAME CLINICAL CATEGORY BUT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM. ADDITIONAL PATIENT DATA WAS PROVIDED BY THE CUSTOMER HOWEVER WAS NOT QUESTIONED AS PART OF THIS EVENT. PATIENT INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1