BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2146071 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01459
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    July 12, 2007
    Report Date
    July 24, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATE PROBES, PERI-PUMP TUBING, WASH ARM LEAD SCREW, MIXER AND MIXER ROLLER ASSEMBLIES, MIXER BELT, AND THE SUBSTRATE PROBE. THE FSE SUCCESSFULLY COMPLETED SYSTEM CHECK AND PERFORMED HS LUMWASH SON-INC TEST WHICH MET SPECIFICATIONS. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS, AND THE INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 TO OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS. RELATED MDRS: 2122870-2011-01460 AND 2122870-2011-01461. THE CUSTOMER COLLECTS SAMPLES IN 12X75 PLASTIC PLASMA SEPARATOR TUBE (PST) SODIUM HEPARIN TUBES WITH GEL. THE CUSTOMER CENTRIFUGES SAMPLES AT 8500 RPM FOR 3 MINUTES IN A STATSPIN CENTRIFUGE. THE SPECIMENS ARE SAMPLED FROM THE PRIMARY TUBES. THE CUSTOMER SENT ONE SERUM AND ONE PLASMA SAMPLE FROM THE PATIENT TO BECKMAN COULTER, INC FOR FURTHER ANALYSIS. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS DURING THE TIME FRAME OF THIS EVENT. THE CUSTOMER PERFORMED A SYSTEM CHECK WHICH PRODUCED FAILING WASHED AND UNWASHED PERCENT VALUES. THE CUSTOMER DID NOT SUPPLY THE ACTUAL SYSTEM CHECK DATA PRINT-OUTS. BECKMAN COULTER, INC CONFIRMED THE CUSTOMER'S RESULTS ON THE NEAT SAMPLE WITH A TROPONIN (ATNI) VALUE OF 7.615 NG/ML. THE ATNI CONCENTRATION SIGNIFICANTLY DECREASED (BY 99%) AFTER THE ADDITION OF A HETEROPHILE BLOCKER. IT IS CONCLUSIVE THAT THE CUSTOMER'S RESULTS ARE FALSELY ELEVATED DUE TO INTERFERING SUBSTANCES IN THE PATIENT BLOOD. THE OCCURRENCE OF SUCH INTERFERENCE IS EXTREMELY LOW. AS ALL MANUFACTURERS, BECKMAN COULTER INC. ADDS ADDITIVES TO PRODUCTS TO LIMIT SUCH AN EFFECT. BUT IN SOME RARE CASES, INTERFERENCE IS SUCH THAT ADDITIVE PRODUCTS ARE NOT EFFICIENT ENOUGH.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED HIGH ERRONEOUS TROPONIN ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT'S SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO SAMPLE NUMBER ONE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2007 WITH EPIGASTRIC PAIN AND WAS TRANSFERRED TO ANOTHER FACILITY WHERE NEGATIVE TROPONIN RESULTS WERE OBTAINED VIA AN ALTERNATE METHOD. THE CUSTOMER SENT SPECIMENS FROM THE PATIENT TO BECKMAN COULTER, INC FOR FURTHER ANALYSIS AND HETEROPHILE INTERFERENCE WAS CONFIRMED. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ACCUTNI ON THE ACCESS IMMUNOASSAY SYSTEMS