BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2565334 · Received May 8, 2012

    Report

    Report Number
    2122870-2012-01303
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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 ON (B)(4) 2012 FOR THIS EVENT. THE CAUSE OF THIS EVENT WAS LOW VACUUM PRESSURE AT THE ASPIRATE PROBE WASH COLLAR MANIFOLD. IT APPEARED THAT THE INNER SLEEVE WAS WORN. THE FIELD SERVICE ENGINEER REPLACED THE WASH COLLAR MANIFOLD. PROACTIVE MEASURES WERE ALSO TAKEN VIA CLEANING OF THE WASH PUMP AND ASSOCIATED VALVES. DISPENSE AND ASPIRATE PROBE VOLUME CHECKS WERE PERFORMED. ADDITIONALLY THE ASPIRATE PERIPUMP TUBING WAS REPLACED AND FLOW RATE VERIFICATIONS WERE PERFORMED. ADDITIONALLY, A GENERAL EVALUATION OF THE WASH ARM AND THE WASH WHEEL FUNCTION WAS PERFORMED. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. MDR ASSOCIATED WITH THIS EVENT: 2122870-2012-01303, 2122870-2012-01310.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS FAST THYROID STIMULATING HORMONE (FTSH) AND PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE GENERATED ON A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS OVER MULTIPLE DATES. THIS REPORT REPRESENTS THE DISCREPANT, ELEVATED FTSH RESULT GENERATED ON A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2012, FOR ONE PATIENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT THIRTY SIX PATIENT RESULTS HAD BEEN PROVIDED. ONLY ONE OF THESE PATIENTS' RESULTS WAS REGARDED AS ERRONEOUS AND HENCE INCLUDED IN THIS REPORT. THIS ERRONEOUS RESULT WAS IDENTIFIED DURING RETESTING OF PREVIOUSLY REPORTED PATIENT RESULTS DUE TO ASSAY QUALITY CONTROL FAILURES. THE INITIAL ERRONEOUS FTSH RESULT WAS ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY. UPON REPEAT ON THE SAME INSTRUMENT, THE RESULT WAS LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, AND REGARDED AS VALID. A CORRECTED REPORT WAS ISSUED. THE DISCREPANT FTSH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED ONLY ONE NOTABLE ASSAY QUALITY CONTROL FAILURE DURING THE TIMEFRAME OF THIS EVENT. THERE WAS NO PATIENT SPECIFIC INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION OR ADDITIONAL SYSTEM PERFORMANCE INFORMATION PROVIDED BY THE CUSTOMER. THE REAGENT LOT NUMBER ASSOCIATED WITH THIS EVENT WAS 170147.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1