BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171146 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02061
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 15, 2008
    Report Date
    January 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYS PERFORMANCE. THE SAMPLES WERE COLLECTED IN THE EMERGENCY ROOM (ER) INTO BD LITHIUM HEPARIN PLASMA PLASTIC TUBE WITH GEL. NUMBER OF TUBE INVERSION AT THE TIME OF COLLECTION WAS NOT SUPPLIED BY THE CUSTOMER. THE SPECIMEN WAS CENTRIFUGED AT 7,200 RPM (ROTATIONS PER MINUTE) FOR 3 MINUTES USING A FIX ANGLED ROTOR. THE SAMPLE WAS ALIQUOTED AND RECENTRIFUGED AT THE SAME CONDITIONS AS THE PRIMARY TUBE. QUALITY CONTROL (QC) WAS IN RANGE PRIOR TO AND FOLLOWING EVENT. SYS CHECKS WERE COMPLETED ON (B)(4) 2008, ON UNIT SERIAL NUMBER (B)(4) AND CONFORMED TO THE MFR'S SPECS. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY RECEIVED BOTH SAMPLES FROM THE PT IN QUESTION FOR FURTHER INVESTIGATION. CPLS REPLICATED THE ELEVATED VALUES WITHIN THE RISK STRATIFICATION RANGE. BOTH SAMPLES SHOWED SIGNIFICANT CHANGES IN DOSE CONCENTRATIONS WITH ADDITIONAL TESTING, CONFIRMING HETEROPHILE INTERFERENCE AS 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 PT 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 I (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 ADD'L 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 ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02040.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN-I (ACCUTNI) RESULTS FOR TWO SAMPLES FROM ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYS. THE RESULTS DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. THIS REPORT REFERS TO UNIT SERIAL NUMBER (B)(4). REPORT NUMBER TWO OF TWO. THE SAMPLES WERE REPEATED, AND THE RESULTS WERE REPRODUCIBLE. THE RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUSPECTED HETEROPHILE INTERFERENCE AND SUPPLIED BECKMAN COULTER, INC WITH THE PT SAMPLES FOR FURTHER ANALYSIS.

    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 37 YR ACCESS ACCUTNI