BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY URIC ACID

    MDR report key: 1930238 · Received December 16, 2010

    Report

    Report Number
    1628664-2010-00486
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 28, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2010 THE CUSTOMER COMPLAINED THAT WHILE USING CLINICAL CHEMISTRY REAGENT LN 07D76-21, LOT 36869UN09 THE ARCHITECT C16000 ANALYZER GENERATED DISCREPANT URIC ACID RESULTS (HIGH) ON THREE PATIENT SAMPLES WITH IGM KAPPA PARAPROTEIN. SAMPLES WERE NOT AVAILABLE FOR RETURN. THE CUSTOMER DATA CONTAINING THE ARCHITECT VALUES COMPARED TO THE ROCHE, SIEMENS VISTA AND SIEMENS ADVIA ANALYZERS SHOWED THE 3 PATIENT RESULTS USING UN-TREATED AND ALSO PRE-TREATED WITH TRICHLOROACETIC ACID (TCA) SAMPLES. THE SAMPLES WERE TREATED TO REMOVE IGM AND PROTEINS AND OBSERVE THE EFFECT ON THE URATE RESULTS. THE RESULTS FOR THE UN-TREATED SAMPLES SHOWED DISCREPANCIES AMONG ALL THE PLATFORMS, NOT ONLY ABBOTT ARCHITECT. HOWEVER, THE PRE-TREATED SAMPLES WITH TCA SHOWED SIMILAR RESULTS AMONG ALL THE PLATFORMS INCLUDING THE ARCHITECT. THE CUSTOMER ALSO COMPARED TO A CONTROL SAMPLE CONTAINING "LOW IGM VALUE" AND ALL PLATFORMS, INCLUDING ABBOTT ARCHITECT, HAD SIMILAR RESULTS ON BOTH, UN-TREATED AND PRE-TREATED SAMPLES. A REVIEW OF THE CALIBRATION CURVE PROVIDED BY THE CUSTOMER SHOWED THAT THE CALIBRATOR VALUES DO NOT CORRESPOND TO ANY OF THE TWO MULTICONSTITUENT CALIBRATOR (MCC) LOTS AVAILABLE IN THE MARKET AT THE TIME OF THIS CALIBRATION. THE CTA CONFIRMED THAT THE CUSTOMER USED A THIRD PARTY RANDOX CALIBRATOR INSTEAD OF THE MCC CALIBRATORS STATED IN THE URIC ACID REAGENT PACKAGE INSERT. THE CTA ALSO INFORMED THAT THE QC WAS WITHIN RANGE. THE INTERFERING SUBSTANCES UNDER THE SPECIFIC PERFORMANCE CHARACTERISTICS SECTION IN THE PACKAGE INSERT STATES "INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES MAY AFFECT RESULTS." A DOCUMENT SEARCH FOUND NO COMPLAINTS FOR THE SAME ISSUE IN THE PRECEDING 6 MONTHS OF COMPLAINT DATA FOR URIC ACID LIST NUMBER 7D76-21. IN ADDITION, THERE ARE NO ADVERSE TRENDS FOR THIS PRODUCT. THERE IS NO INDICATION OF A DEFICIENCY FOR THE URIC ACID REAGENT LN 07D76-21, LOT 36869UN09. A SURVEY OF PUBLISHED ARTICLES INDICATES THAT PATIENT SAMPLES WITH HIGH MONOCLONAL IGM MAY BE CAUSING HIGHER THAN EXPECTED URIC ACID RESULTS DUE TO INTERFERENCE AND THE CUSTOMER USED DIFFERENT CALIBRATORS (RANDOX) THAN THOSE STATED IN THE URIC ACID REAGENT PACKAGE INSERT (MCC). THE CUSTOMER WAS REFERRED TO THE PUBLISHED ARTICLES AND ALSO THE PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE FROM A PATIENT KNOWN TO HAVE LYMPHOMA WITH IGM PARAPROTEINS WAS PROCESSED USING THE ARCHITECT URIC ACID ASSAY GENERATING A ALLEGED FALSELY ELEVATED RESULT. THE CUSTOMER STATES THAT THE HIGHER THAN EXPECTED RESULT MAY BE ATTRIBUTED TO PARAPROTEIN INTERFERENCE WITH THE ASSAY. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE. THE SAMPLE WAS TESTED USING ALTERNATE METHODS WITH VARYING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY URIC ACID FOR THE QUANTITATION OF URIC ACID IN HUMAN SERUM, PLASMA, OR URINE. CGZ ABBOTT MANUFACTURING, INC. 36869UN09

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C16K ANALYZER LN 3L77-01 SN (B)(4)