BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172502 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01982
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 28, 2007
    Report Date
    November 29, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM VERIFICATION. SYSTEM CHECK SUCCESSFULLY PASSED. SON/INC. TEST FAILED. THE FSE REPLACED ALL PROBES. THE FSE DISCOVERED ASPIRATE PROBES PITTED, ETCHED, AND DULL IN APPEARANCE. THE FSE REPLACED SUBSTRATE PROBE LINE DUE TO KINK. THE FSE REPLACED THE MIXER PINCH ROLLERS AS A PRECAUTION. THE FSE PERFORMED A SECOND SON/INC. TEST, AND THE RESULTS PASSED SUCCESSFULLY. THE UNIT WAS RETURNED TO OPERATION. THE SAMPLE COLLECTED IN THE EMERGENCY ROOM (ER) INTO BD PLASTIC GEL TUBE. THE SAMPLE TYPE WAS LITHIUM HEPARIN PLASMA. THE SAMPLE DID NOT APPEAR LIPEMIC OR HEMOLYZED. DRAW VOLUME WAS ADEQUATE. CENTRIFUGATION OCCURRED AT >5,000 RPM (ROTATION PER MINUTE) FOR 8 MINUTES. SAMPLE 1 WAS RE-SPUN AT 13,000 RPM FOR 3 MINUTES PRIOR TO REPEAT. STORAGE DETAILS WERE NOT SUPPLIED BY THE CUSTOMER. QUALITY CONTROL (QC) RESULTED IN RANGE PRIOR TO AND FOLLOWING THE EVENT. SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2007, AND RESULTS CONFORMED TO SPECIFICATIONS. THE CUSTOMER PERFORMED CALIBRATION VERIFICATION FOR THE LOT NUMBER IN USE ON (B)(4) 2007, AND THE MATERIAL CONFORMED TO ACCEPTANCE CRITERIA. NO ERRORS WERE RECEIVED IN THE EVENT LOG NEAR THE TIMES OF SAMPLE COMPLETION. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTED THE PT SAMPLE AND CONCLUDED CIRCULATING HETEROPHILE ANTIBODIES CAUSED INTERFERENCE WITH THE TROPONIN (ACCUTNI) ASSAY. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THE EVENT. PRODUCT LABELING: FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PTS WHO HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING MONOCLONAL ANTIBODIES OR IN INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES, SUCH AS HUMAN ANTI-GOAT ANTIBODIES, MAY BE PRESENT IN PT SAMPLES. IN ADDITION, ELEVATED TROPONIN-I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS TROPONIN (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN-I (ACCUTNI) RESULTS BELOW THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FROM ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE ELEVATED RESULTS WERE REPRODUCIBLE. A NEGATIVE TROPONIN RESULT WAS OBTAINED VIA AN ALTERNATE METHODOLOGY. THE RESULTS WERE REPORTED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLE FOR FURTHER ANALYSIS. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ACCESS ACCUTNI