BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171157 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02089
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) ASSESSED THE UNIT ON (B)(4) 2008. THE FSE PERFORMED A MAJOR PLANNED MAINTENANCE (PM). THE FSE REPLACED THE MIXER ASSEMBLIES, PINCH ROLLERS AND THE INCUBATOR BELT. THE FSE PERFORMED REPAIR VERIFICATION PER ESTABLISHED PROCEDURES. THE RESULTS CONFORMED TO PUBLISHED PERFORMANCE SPECS. SYSTEM VALIDATION DOCUMENTED IN THE CUSTOMER'S QUALITY CONTROL (QC) RECORD. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PT SAMPLE. PTS 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 PT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PTS SUSPECTED OF HAVING THESES ANTIBODIES. THE ACCESS CREATINE KINASE-MB (CK-MB) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADD'L TESTS AND OTHER APPROPRIATE INFO. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW CREATINE KINASE MB (CK-MB) RESULT FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS 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 UNK ACCESS CK-MB